BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND SUTURE CARTRIDGE SIZE 3-0

    MDR report key: 3234064 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13708
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    September 20, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GAT
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES DILATION & CURETTAGE, CHOLECYSTECTOMY, LAVH, BSO AND LYSIS ADHESIONS ON 06/30/2010. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334246 ETHIBOND SUTURE CARTRIDGE SIZE 3-0 SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON ENDO-SURGERY, LLC. UNK 3389842

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention