BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIMESH

    MDR report key: 2218348 · Received July 19, 2011

    Report

    Report Number
    2032582-2011-00003
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS SOLD AND IMPLANTED IN (B)(6). SIMILAR DEVICES ARE SOLD IN THE U.S. AT THIS TIME PFM MEDICAL DOES NOT HAVE ENOUGH INFO TO COMPLETE A THOROUGH INVESTIGATION OF THE MENTIONED FAILURE MODE. PFM HAS REQUESTED FURTHER INFO FROM THE COMPLAINANT. WHEN THIS ADDITIONAL INFO BECOMES AVAILABLE PFM MEDICAL, INC SHALL BE FILING A FOLLOW UP REPORT TO FURTHER EXPLAIN THE COMPLAINT ON HAND.

    Description of Event or Problem · 1

    SURGERY CONDUCTED IN (B)(6). THE IMPLANTATION SURGERY WAS CONDUCTED IN (B)(6) OF 2009. A FOLLOW-UP SURGERY WAS CONDUCTED IN (B)(6) OF 2011. THE CLIENT REPORTED: "IN (B)(6) 2009 PT HAD A BILATERAL INGUINAL HERNIA SURGERY USING TIMESH. AFTER THAT, PT WAS COMPLAINING OF POSTOPERATIVE PAIN (COMPATIBLE WITH INTESTINAL SUB OCCLUSION). DURING A REVISION (PLACED AT (B)(6) 2011) WAS FOUND STRONG ADHESION ON BOTH TIMESH AND ALSO INTRA-ABDOMINAL ADHESIONS WITH INTESTINAL LOOP INJURY." THE PRODUCT IN QUESTION WAS NOT RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH MESH, SURGICAL, POLYMERIC FTL PFM MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention