BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUTURE 30"(75CM) 2-0 BLU

    MDR report key: 12675767 · Received October 21, 2021

    Report

    Report Number
    2210968-2021-10119
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031021037
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/17/2021. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL NARRATIVE: AN EMPTY LABELED WINDING FORMER, AND A DISPENSED NEEDLE/SUTURE PRODUCT CODE 8833 WERE RETURNED TO ETHICON INC FOR ANALYSIS WITH THE PACKAGING PREVIOUSLY OPENED. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURE WAS RECEIVED DISPENSED AND EXAMINED ALONG OF THE STRAND TO DETECT ANY ISSUE RELATED TO DAMAGED OR BREAKAGE SUTURE AND NO DEFECTS WERE OBSERVED DURING EVALUATION. FUNCTIONAL TEST WAS PERFORMED, AND THE TENSILE STRENGTH RESULT WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT THE SURGICAL TECHNIQUE WAS CHANGED AND POSE OF A PLATE THAT WAS NOT INITIALLY INDICATED IN THE CARE OF A STRANGULATED INGUINAL HERNIA : DID THE CHANGE IN SURGICAL TECHNIQUE CAUSE ANY ADDITIONAL TISSUE DISSECTION OR TISSUE DAMAGE? NO. WAS THERE ANY ADDITIONAL POST-OP CARE DUE TO THE CHANGE IN SURGICAL TECHNIQUE? NO. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED AS A RESULT? NO. 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 Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT WAS REPORTED THAT THE SURGICAL TECHNIQUE WAS CHANGED AND POSE OF A PLATE THAT WAS NOT INITIALLY INDICATED IN THE CARE OF A STRANGULATED INGUINAL HERNIA : DID THE CHANGE IN SURGICAL TECHNIQUE CAUSE ANY ADDITIONAL TISSUE DISSECTION OR TISSUE DAMAGE? WAS THERE ANY ADDITIONAL POST-OP CARE DUE TO THE CHANGE IN SURGICAL TECHNIQUE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED AS A RESULT? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED IN 2210968-2021-10117, 2210968-2021-10118, 2210968-2021-10119 AND 2210968-2021-10120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD SPLIT SEVERAL TIMES AT DIFFERENT PLACES ALONG THE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568950 PROLENE SUTURE 30"(75CM) 2-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8833H 10705031021037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown