BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 19940021 · Received August 8, 2024

    Report

    Report Number
    2210968-2024-08214
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    May 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PLEASE PROVIDE THE MESH EXPOSURE SITE/LOCATION, SYMPTOMS AND DIAGNOSTIC CONFIRMATION. WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? PRODUCT CODE AND/OR LOT NUMBER? TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2024 AND MESH WAS IMPLANTED. ON (B)(6) 2024, THEY TRIED TO CLOSE MESH EROSION WITH NO LUCK. ON (B)(6) 2024, THE PATIENT WAS REFERRED DUE TO EROSION OF THE MESH FOLLOWING EROSION WITH REOPERATION WHERE THE EXPOSED PIECE WAS COVERED WITH MUCOUS MEMBRANE. ON (B)(6) 2024, THE PATIENT UNDERWENT REMOVAL OF FOREIGN BODY FROM THE VAGINA, 4 CM EROSION. THE LOOP IS FREE DISSECTED ON BOTH SIDES. THE VAGINAL PART OF THE SLING IS REMOVED. SLING SENT TO D+R AND FOUND GROWTH OF PENICILLIN SENSITIVE STREPTOCOCCI. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396273 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention