BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 4210489 · Received October 29, 2014

    Report

    Report Number
    2210968-2014-15136
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT OPEN INCISIONAL UMBILICAL HERNIA REPAIR ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ERYTHEMA ON THE RIGHT SIDE OF THE INCISION. THE PATIENT WAS TREATED PROPHYLACTICALLY WITH ORAL DOXYCYCLINE FOR 10 DAYS. THE SURGEON OPINES THE ERYTHEMA IS MOST LIKELY DUE TO SUBCUTANEOUS DISSECTION. THE PATIENT IS HEALING WELL WITH NO PROBLEMS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT OPEN INCISIONAL UMBILICAL HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ERYTHEMA ON THE RIGHT SIDE OF THE INCISION. THE PATIENT WAS TREATED PROPHYLACTICALLY WITH ORAL DOXYCYCLINE FOR 10 DAYS. THE SURGEON OPINES THE ERYTHEMA IS MOST LIKELY DUE TO SUBCUTANEOUS DISSECTION. THE PATIENT IS HEALING WELL WITH NO PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RECURRENT OPEN INCISIONAL UMBILICAL HERNIA REPAIR ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, THE PATIENT EXPERIENCED ERYTHEMA ON THE RIGHT SIDE OF THE INCISION. THE PATIENT WAS TREATED PROPHYLACTICALLY WITH ORAL DOXYCYCLINE FOR 10 DAYS. THE SURGEON OPINES THE ERYTHEMA IS MOST LIKELY DUE TO SUBCUTANEOUS DISSECTION. THE PATIENT IS HEALING WELL WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691739 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention