BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR PELVIC FLOOR REPAIR

    MDR report key: 15697757 · Received October 31, 2022

    Report

    Report Number
    2210968-2022-08956
    Event Type
    Injury
    Date Received
    October 31, 2022
    Report Date
    October 31, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    UDI-DI
    10705031062320
    PMA / PMN Number
    K071512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/21/2022. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED INFORMATION: D4 (PRIMARY UDI NUMBER), G4 *IT WAS IDENTIFIED THAT THIS COMPLAINT WAS INADVERTENTLY REPORTED WITH THE INCORRECT PREDICATE 510K DEVICE NUMBER, K013718, INSTEAD OF K071512.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A MICROWAVE ENDOMETRIAL ABLATION AND POSTERIOR PELVIC FLOOR REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEAVY VAGINAL BLEEDING AND PERSISTENT DISCHARGE, PELVIC PAIN, DYSPAREUNIA, FAECAL INCONTINENCE, SOILING, URGENCY, LOWER ABDOMINAL PAIN, CYSTS, CYSTOCELE, VAGINAL ABSCESS AND VAGINAL SWELLING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764389 POSTERIOR PELVIC FLOOR REPAIR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 810081 3422151 10705031062320
    2779273 POSTERIOR PELVIC FLOOR REPAIR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 810081 3422151 10705031062320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention