BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIFMESH SOFT TISSUE PATCH

    MDR report key: 2824960 · Received October 29, 2012

    Report

    Report Number
    3004859928-2012-00033
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 18, 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

    DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION: INCONCLUSIVE, INVESTIGATION ONGOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM PTFE. COMPLICATIONS SUCH AS ADHESION FORMATION 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)(6) 2012, VIA E-MAIL BY THE MOTIFMESH DISTRIBUTOR IN THE US ((B)(4)) THAT THEY HAVE REC'D A COMPLAINT REGARDING A MOTIFMESH PRODUCT. THE COMPLAINT STATES THAT PT IDENTIFIED AS "(B)(6)" HAD A VENTRAL HERNIA REPAIR WITH MOTIFMESH ON (B)(6) 2012. THE PT DEVELOPED SMALL BOWEL ADHESIONS WHICH LED TO A SMALL BOWEL OBSTRUCTION. THE PT WAS TREATED IN HOSPITAL FOR 5 DAYS ((B)(6) 2012), WITH IV FLUIDS AND NASO-GASTRIC TUBING AND WAS THEN DISCHARGED. THE PT DID NOT UNDERGO SURGERY TO REPAIR THE ADHESIONS OR REMOVE THE MOTIFMESH IMPLANT. THE PT WAS (B)(6) OF AGE AT THE TIME OF SURGERY. (B)(6). THE PT MADE A FULL RECOVERY. THE HOSPITAL WHERE THE PROCEDURE TOOK PLACE IS (B)(6). THE SURGERY WAS PERFORMED BY DR (B)(6). THE IMPLANT INVOLVED IN THIS COMPLAINT IS A MOTIFMESH 20 X 30CM MESH, PART NUMBER PTSE2030. THE LOT NUMBER OF THE MOTIFMESH IMPLANT IS C001046. NO FURTHER INFO REGARDING THE PT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTIFMESH SOFT TISSUE PATCH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD PTSE2030 C001046

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other