BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIFMESH SOFT TISSUE PATCH

    MDR report key: 2782077 · Received October 2, 2012

    Report

    Report Number
    3004859928-2012-00028
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 27, 2012
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K052100
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION - INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM PTFE. COMPLICATIONS SUCH AS ADHESIONS ARE A DOCUMENTED RISK ASSOCIATED WITH THE MOTIMESH DEVICE - REFERENCE DESIGN FMEA AND MOTIFMESH PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED (B)(6) 2012, VIA EMAIL BY THE MOTIMESH DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT REGARDING A MOTIFMESH PRODUCT. THE MOTIFMESH HAD ADHERED TO THE SMALL BOWEL. THE MESH WAS REMOVED, THE PATIENT MADE A FULL RECOVERY. THE PATIENT IS A (B)(6) OBESE MALE WHO HAS HAD MULTIPLE GASTRIC SURGERIES IN RECENT YEARS. NOTE: MOTIFMESH IS BRANDED AS OMYRA MESH IN EUROPE BY THE DISTRIBUTOR (B)(4). THE COMPLAINT WAS REPORTED TO (B)(4) BY MR (B)(6) (CONSULTANT SURGEON AT (B)(6)) IN A LETTER SENT ON (B)(6) 2012. THE PATIENT MADE AN "UNEVENTFUL RECOVERY" FOLLOWING MESH REMOVAL. NO FURTHER INFORMATION REGARDING THE PATIENT IS AVAILABLE. THE MOTIFMESH LOT NUMBER HAS NOT BEEN PROVIDED BY THE COMPLAINANT. THE COMPLAINT CONTAINS DETAILS OF A PATIENT ((B)(6) OBESE MALE), WHO HAD THE MOTIFMESH IMPLANTED BY MR (B)(6) FOR INCISIONAL HERNIA REPAIR. THE MESH WAS PLACED ON THE INTRAPERITONEAL ASPECT (ATTACHED TO THE DEEPEST LAYER OF THE ABDOMINAL WALL IN CONTACT WITH THE ABDOMINAL ORGANS AND OMENTUM) FOLLOWING AN UPPER MIDLINE INCISION. THE MESH WAS TACKED IN PLACE, TO THE FASCIA OF THE POSTERIOR ABDOMINAL WALL WITH A SERIES OF INTERRUPTED 2/0 PDS SUTURES (ETHICON). THE PATIENT DEVELOPED A LEFT SUBPHRENIC ABSCESS (BETWEEN THE DIAPHRAGM AND SPLEEN/STOMACH/PANCREAS) AND THE PATIENT REQUIRED FURTHER SURGERY TO CORRECT THIS, TWO WEEKS AFTER THE IMPLANTATION SURGERY. THE SURGEON NOTICED THAT EXTENSIVE AND DENSE ADHESIONS THAT HAD FORMED BETWEEN THE SMALL BOWEL AND OMENTUM (A LAYER OF FATTY TISSUE BETWEEN THE ABDOMINAL ORGANS AND THE POSTERIOR ABDOMINAL WALL) AND THE UNDERSIDE OF THE MOTIFMESH. THE MESH WAS REMOVED HOWEVER PARTS OF THE EXTERIOR LAYERS OF THE SMALL BOWEL AND OMENTAL FAT CAME AWAY WITH THE MESH. THE SMALL BOWEL WAS NOT PERFORATED. THE PATIENT, SOME YEARS PREVIOUSLY, UNDERWENT GASTRIC SURGERY FROM WHICH THE INCISIONAL HERNIA AROSE. THE HERNIA REPAIR SURGERY WAS ALSO COMBINED WITH A SUBTOTAL GASTRECTOMY TO TREAT GASTRIC HYPOMOTILITY. THE PATIENT MADE AN "UNEVENTFUL RECOVERY" FOLLOWING MESH REMOVAL. NO FURTHER INFORMATION REGARDING THE PATIENT IS AVAILABLE. DEVICE LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTIFMESH SOFT TISSUE PATCH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 20 CM X 30 CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other