BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH RECTANGULAR

    MDR report key: 3771032 · Received April 24, 2014

    Report

    Report Number
    2210968-2014-05249
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. IT WAS FOLDED SEVERAL TIMES AND THE LAYERS WERE ADHERED TO EACH OTHER. THE CAUSE FOR THE EVENT COULD NOT BE VERIFIED WITH THE EXPLANTED SAMPLE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC IPOM INCISIONAL HERNIA REPAIR PROCEDURE AND MESH WAS IMPLANTED. APPROXIMATELY TWO WEEKS FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF FLUID AT THE PROCEDURE SITE. THE PATIENT WAS HOSPITALIZED AND 2 LITERS OF FLUID WERE DRAINED FROM THE ABDOMINAL WALL. ON (B)(6) 2014 A REOPERATION WAS DONE TO DETERMINE THE STATUS OF THE MESH AND SITE OF FLUID COLLECTION. DURING THE REOPERATION IT WAS NOTED THAT THE MESH WAS FREELY FLOATING IN THE ABDOMEN. IT WAS DETERMINED THAT AN (B)(6) INFECTION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249752 PHYSIOMESH RECTANGULAR MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK GP8DKPB0

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R