BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 36IN 3-0 D/A SH

    MDR report key: 11021361 · Received December 16, 2020

    Report

    Report Number
    2210968-2020-10000
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 26, 2020
    Report Date
    November 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031016569
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4) DATE SENT TO THE FDA: 1/7/2021   ADDITIONAL INFORMATION: H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.   ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM THE CORRECT ALERT DATE AND PROCEDURE DATE =>THE ALERT DATE IS (B)(6)2020. THE PROCEDURE DATE IS (B)(6) 2020. -IF YOU SEE THE ALERT DATE AS 11/25, IT WOULD BE PROBABLY DUE TO THE TIME ZONE DIFFERENCE, MEANING, THE ALERT DATE IS PROBABLY DISPLAYED BY THE LOCAL TIME. 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, 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 · 1

    (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? THE SUTURES BROKE WHILE USING THEM FOR FIXING THE MESH ( OF MEDICON COMPANY.) IT IS UNKNOWN WHAT TISSUE WAS SUTURED. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE SUTURE BREAKAGE/SMOOTHNESS OF THE SUTURE SURFACE WAS QUITE BAD? NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED. 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. ALERT DATE IS (B)(6) 2020 AND PROCEDURE DATE IS (B)(6) 2020. PLEASE CONFIRM THE CORRECT ALERT DATE AND PROCEDURE DATE IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL WALL SCAR HERNIA SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487980 PRLNE BLU 36IN 3-0 D/A SH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8522H PKB834 10705031016569

    Patients

    Seq Age Sex Outcome Treatment
    1