BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIFMESH SOFT TISSUE PATCH

    MDR report key: 2801458 · Received October 19, 2012

    Report

    Report Number
    3004859928-2012-00030
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 16, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM (B)(4). COMPLICATIONS SUCH AS INFECTION ARE A DOCUMENTED RISK ASSOCIATED WITH THE MOTIFMESH DEVICE - REFERENCE DESIGN FMEA AND MOTIFMESH PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED (B)(4) 2012 VIA EMAIL BY THE MOTIFMESH DISTRIBUTOR IN THE US ((B)(4)) THAT THEY HAVE REC'D A COMPLAINT REGARDING A MOTIFMESH PRODUCT. THE PRODUCT WAS IMPLANTED IN A PT TO REPAIR A VENTRAL HERNIA ON (B)(6) 2011. THE PT SUFFERED PAIN AND WAS TREATED WITH PAINKILLERS. THE PT DEVELOPED AN INFECTION WHICH WAS CONSIDERED BY THE SURGEON TO HAVE ORIGINATED FROM THE MESH PLUG (MARLEX) THAT WAS IMPLANTED DURING A PREVIOUS SURGERY. THE PT DEVELOPED AN ABSCESS IN THE REGION OF THE MOTIFMESH WHICH WAS TREATED WITH ANTIBIOTICS. THE MESH WAS REMOVED ON (B)(6) 2012 AND THE HERNIA WAS REPAIRED WITH SUTURES TEMPORARILY UNTIL THE INFECTION SUBSIDED. THE PT IS IDENTIFIED AS '(B)(6)' AND SHE WAS (B)(6) AT THE TIME THE SURGERY TOOK PLACE. SHE HAS A BMI OF (B)(6). THE HOSPITAL WHERE THE PROCEDURE TOOK PLACE IS (B)(6) SCHOOL OF MEDICINE, (B)(6). THE SURGERY WAS PERFORMED BY DR (B)(6). NO FURTHER INFO REGARDING THE PT IS AVAILABLE. THE MOTIFMESH LOT NUMBER HAS NOT BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other