BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT-ABBREVO MINI LCM

    MDR report key: 15284048 · Received August 24, 2022

    Report

    Report Number
    2210968-2022-06884
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062368
    PMA / PMN Number
    K100936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3940998 AND PRODUCT CODE TVTOML.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT TO FDA: 10/25/2022 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. ADDITIONAL INFORMATION: H3, H6 H3 ANALYSIS SUMMARY: RECEIVED FOR EVALUATION WAS A PART OF TVTOML (TVT ABBREVO) DEVICE, BATCH 3940998. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED, AS IT WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING, THE BLISTER IS MISSING. - BOX AND LID - THE BOX AND LID WERE RECEIVED COMPLETELY FOLDED, THE IDENTIFICATION LABEL IS PRESENT IN THE TWO COMPONENTS AND CORRESPONDS TO LOT NUMBER 3940998. NO OTHER DAMAGES WERE FOUND. - TROCARS - NO DAMAGES WERE DETECTED DURING THE EVALUATION. - BLUE MESH - IT CAN BE OBSERVED THAT THE MESH WAS CUT IN TWO PARTS. AFTER VERIFICATION WITH A CALIBRATED GAUGE, THE MESH DID NOT MEET THE REQUIREMENTS OF NEUCHATEL MANUFACTURING, ONE PART OF THE MESH IS MISSING. NO OTHER DAMAGES WERE OBSERVED. - NEEDLES - THE TWO NEEDLES HAVE BEEN VERIFIED AND NO DAMAGES WERE OBSERVED. - BUTTON OF POSITIONING LOOP - NO DAMAGES WERE DETECTED DURING THE EVALUATION. - WINGED GUIDE - NO DAMAGES WERE DETECTED DURING THE EVALUATION. THE BATCH RECORD REVIEW HAD SHOWN THAT THE PRODUCT WAS CONFORMING TO SPECIFICATIONS AT RELEASE. THE DEFECT ON DEVICE SEEN DURING THE PRODUCT EVALUATION IS ALIGNED WITH THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION ("THE ENTIRE SLING IS WAS HANGING ON A THREAD AND THE MESH SPLIT IN HALF"). BASED ON THE EVALUATION, THIS COMPLAINT IS NOT A MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 09/14/2022. 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 DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND MESH WAS USED. WHEN THE PRODUCT WAS OPENED IN THEATRE IN PREPARATION TO BE PLACED INTO THE PATIENT, THE ENTIRE SLING WAS HANGING ON A THREAD AND THE MESH SPLIT IN HALF. THE PRODUCT WAS NOT USED IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829189 GYNECARE TVT-ABBREVO MINI LCM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTOML 3940998 10705031062368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown