BEUDAMED
    FDA Adverse Event Summary report: N

    MOTIFMESH SOFT TISSUE PATCH

    MDR report key: 4344539 · Received December 10, 2014

    Report

    Report Number
    3004859928-2014-00055
    Date Received
    December 10, 2014
    Report Date
    December 8, 2014
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K052100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE COMPLAINT IS UNKNOWN DUE TO LACK OF INFORMATION, HOWEVER, IT IS SUSPECTED THAT A MESH TEAR WAS INDUCED DURING THE SURGICAL CLAMPING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMS THAT THE LOT MET ITS MANUFACTURING SPECIFICATIONS; THE REVIEW DID NOT IDENTIFY ANYTHING ATYPICAL WITH THE MANUFACTURING OF THE DEVICE LOT THAT MAY POTENTIALLY HAVE CONTRIBUTED TO THE MESH TEARING IN CLINICAL USE.

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON (B)(6) 2014 VAI EMAIL BY THE OMYRA MESH DISTRIBUTOR (BBRAUN, (B)(4)) THAT THEY RECEIVED A COMPLAINT REGARDING AN OMYRA MESH PRODUCT (PART #1061522, LOT #C002071). THE COMPLAINT WAS REPORTED TO B.BRAUN BY (B)(6) HOSPITAL, (B)(6). THE COMPLAINTS REPORTS THAT THE OMYRA MESH WAS "RIPPED DURING THE CLAMPING PROCESS" - THE PHYSICIAN STATED THAT THE TEAR DID NOT AFFECT THE PROCEDURE OUTCOME AND HE DID NOT REMOVE THE IMPLANTED MESH FROM THE PATIENT. THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT DUE TO THE MESH TEAR. NO FURTHER INFORMATION WAS PROVIDED. NOTE: OMYRA MESH WHICH IS DISTRIBUTED IN (B)(4) BY BBRAUN, IS BRANDED AS MOTIFMESH IN THE USA (REF. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797568 MOTIFMESH SOFT TISSUE PATCH MESH SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 1061522 C002071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK