BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 2215299 · Received August 17, 2011

    Report

    Report Number
    2210968-2011-01108
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: ANTERIOR PROLIFT + M PELVIC FLOOR REPAIR. POSTERIOR PROLIFT + M PELVIC FLOOR REPAIR.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: ANTERIOR PROLIFT + M PELVIC FLOOR REPAIR : PRODUCT CODE PFRA02, BATCH 3242271, EXP DATE 09/30/2011, MFG DATE 12/11/2008. POSTERIOR PROLIFT + M PELVIC FLOOR REPAIR : PRODUCT CODE PFRP02, BATCH NI, EXP DATE NI, MFG DATE NI. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO REPAIR STRESS INCONTINENCE AND UTEROVAGINAL PROLAPSE ON (B)(6) 2009 AND ANTERIOR PELVIC FLOOR REPAIR MESH AND POSTERIOR PELVIC FLOOR REPAIR MESH WERE USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT THE PATIENT HAD SURGICAL PROCEDURES FOR MESH REMOVAL ON (B)(6) 2010 AND (B)(6) 2011. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(6). (B)(4). ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: ANTERIOR PROLIFT + M PELVIC FLOOR REPAIR : PRODUCT CODE PFRA02, BATCH AM8DTPZ0; POSTERIOR PROLIFT + M PELVIC FLOOR REPAIR : PRODUCT CODE PFRP02, BATCH AM8DTOZ0.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO REPAIR STRESS INCONTINENCE ON (B)(6) 2008 AND ANTERIOR PELVIC FLOOR REPAIR MESH AND POSTERIOR PELVIC FLOOR REPAIR MESH WERE USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention