BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII CLR 27IN 2-0 S/A PS PRM

    MDR report key: 15472529 · Received September 23, 2022

    Report

    Report Number
    2210968-2022-07813
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: HOW MANY INDIVIDUAL DEVICES (EACHES) OF REPEATED SNAPPING OCCURRED DURING THIS SINGLE PROCEDURE ? 16 SUTURES. PLEASE CLARIFY IF THE NEEDLE SEPARATED FROM THE SUTURE OR DID THE SUTURE BREAK DURING THIS SINGLE PROCEDURE? SUTURES BREAKING. PRODUCT CODE W9626T. LOT: SDMAZQ. I AM STILL WAITING ON A BIT MORE INFORMATION REGARDING THE PROCEDURE 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. EVENTS REPORTED ON MW# 2210968-2022-07348, MW# 2210968-2022-07349, MW # 2210968-2022-07801, MW # 2210968-2022-07803, MW # 2210968-2022-07805, MW # 2210968-2022-07806, MW # 2210968-2022-07807, MW # 2210968-2022-07808, MW # 2210968-2022-07809, MW # 2210968-2022-07810, MW # 2210968-2022-07811, MW # 2210968-2022-07812, MW # 2210968-2022-07814, MW # 2210968-2022-07815, & MW # 2210968-2022-07816.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SUBCUTANEOUS TISSUE CLOSURE AND SUTURE SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727760 PDSII CLR 27IN 2-0 S/A PS PRM SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SDMAZQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown