BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDURAGEN

    MDR report key: 830701 · Received March 12, 2007

    Report

    Report Number
    9617613-2007-00008
    Event Type
    Other
    Date Received
    March 12, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 12, 2007
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR 04B20-1, ALL PROCESS AND TEST CRITERIA HAS BEEN VERIFIED AS COMPLYING WITH THE ENDURAGEN FINISHED PRODUCT SPEC. THE INVESTIGATION CONCLUDED SATISFACTORY PROCESSING AND PACKAGING OF TISSUE AND RESULTANT TESTING OF PRODUCT. THERE WAS NO EVIDENCE TO SUGGEST ANY REASON FOR POTENTIAL PRODUCT ABSORPTION, STERILITY OR TENSILE STRENGTH CONCERNS.

    Description of Event or Problem · 1

    THE PT HAD A RHINOPLASTY REVISION USING AN EXTERNAL APPROACH WITH ENDURAGEN IMPLANTED AS A BRIDGE ONLAY GRAFT MATERIAL FOR A SMALL SADDLE DEFORMITY. THE PT CALLED THE OFFICE APPROX SIX WEEKS POSTOPERATIVELY AND STATED THAT OVER THE PAST FEW DAYS SHE HAD NOTED THE DEPRESSION IN HER BRIDGE HAD RETURNED. THE PT RETURNED TO THE OPERATING ROOM AND AN AURICULAR CARTILAGE GRAFT WAS USED TO FILL IN THE DEPRESSION WHERE THE ENDURAGEN ONCE WAS. ANOTHER PIECE OF ENDURAGEN WAS THEN PLACED AS AN OVERLAY TO MINIMIZE THE TRANSLATION OF ANY IRREGULARITIES TO THE SKIN SURFACE. TRANSCUTANEOUS SUTURES WERE USED AS WELL AS PDS SUTURE MATERIAL PLACED UNDER THE NASAL SKIN. THE TRANSCUTANEOUS SUTURES WERE LEFT IN FOR ONE WEEK POSTOPERATIVELY UNDER A STANDARD CAST AND BANDAGE. NOTHING UNUSUAL WAS SEEN AT THE SUTURE SITE AT THE ONE-WEEK POSTOPERATIVE VISIT. THE SURGEON COMMENTED THAT HE HAD USED ENDURAGEN MANY TIMES OVER THE PAST FIVE YEARS, AND THIS WAS THE FIRST TIME WHERE IT SEEMED TO HAVE RESORBED AND DONE SO IN A VERY SHORT AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURAGEN PORCINE DERMAL IMPLANT FTM TISSUE SCIENCE LABORATORIES, PLC NA 04B20-1

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other