ALLODERM SELECTTM Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION
ALLODERM SELECTTM Regenerative Tissue Matrix (ALLODERM SELECTTM RTM refers to both ALLODERM SELECTTM RTM and ALLODERM SELECT RESTORETM RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. This product is intended for single patient one-time use only. ALLODERM SELECTTM RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.
IMPORTANT SAFETY INFORMATION
ALLODERM SELECTTM RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECTTM RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.
DO NOT re-sterilize ALLODERM SELECTTM RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECTTM RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECTTM RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
ALLODERM SELECTTM RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum
of 2 minutes using a sterile basin and room temperature sterile saline or room
temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is
visible, remove using aseptic technique before implantation.
ALLODERM SELECTTM RTM should be hydrated and moist when the package
is opened. DO NOT use if this product is dry. Use of this product is limited to
specific health professionals (e.g., physicians, dentists, and/or podiatrists).
Certain considerations should be made to reduce the risk of adverse events when
performing surgical procedures using a tissue graft. Please see the Instructions
for Use (IFU) for more information on patient/product selection and surgical
procedures involving tissue implantation before using ALLODERM SELECTTM RTM.
The most commonly reported adverse events associated with the implant of
a tissue graft include, but are not limited to the following: wound or systemic
infection; seroma; dehiscence; hypersensitive, allergic or other immune response;
and sloughing or failure of the graft.
ALLODERM SELECTTM RTM is available by prescription only.
For more information, please see the Instructions for Use (IFU) for ALLODERM
SELECTTM RTM available at www.allergan.com/AlloDermIFU or call
To report an adverse reaction, please call Allergan at 1.800.433.8871.