BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL PRODUCT

    MDR report key: 2840335 · Received October 8, 2012

    Report

    Report Number
    9617613-2012-00217
    Event Type
    Injury
    Date Received
    October 8, 2012
    Report Date
    May 15, 2020
    Manufacturer
    COVIDIENT, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER: (B)(4). SUPPLEMENTAL MDR# 01 SENT TO FDA ON 04/26/2013.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADDITIONAL INFORMATION FROM IMPORTER REPORT: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED BY THE PATIENT' S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. JOHNSON + JOHNSON TVT TAPE WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL PRODUCT PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R JOHNSON & JOHNSON TVT TAPE| JOHNSON & JOHNSON TVT TAPE| JOHNSON & JOHNSON TVT TAPE