BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPROPYLENE

    MDR report key: 9131344 · Received September 27, 2019

    Report

    Report Number
    3012164473-2019-00024
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAW
    UDI-DI
    10790986003559
    PMA / PMN Number
    K001185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT AMENDED TO REFELECT TEST RESULTS FROM ISSUE SAMPLE. - ATTACHMENT: [LOT# 181227-54 RETAIN SAMPLE TENSILE TEST.PDF, LOT# 181227-54 RETURN SAMPLE TENSILE TEST.PDF].

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIZE 4/0 POLYPROPYLENE SUTURE BROKE DURING NORMAL PROCEDURE. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. THE ONLY KNOWN INFORMATION IS THE PRODUCT NUMBER. (8682P) EITHER LOT# 190425-56 OR LOT# 181227-54 IS ASSOCIATED WITH THE EVENT. TESTING AND INVESTIGATION WAS COMPLETED ON BOTH LOTS FOR DOCUMENTATION PURPOSES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. AMENDMENT: TESTING AND INVESTIGATION WAS COMPLETED PER ISSUE LOT# 181227-54.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIZE 4/0 POLYPROPYLENE SUTURE BROKE DURING NORMAL PROCEDURE. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. THE ONLY KNOWN INFORMATION IS THE PRODUCT NUMBER. (8682P) EITHER LOT# 190425-56 OR LOT# 181227-54 IS ASSOCIATED WITH THE EVENT. TESTING AND INVESTIGATION WAS COMPLETED ON BOTH LOTS FOR DOCUMENTATION PURPOSES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926155 POLYPROPYLENE POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE,, GAW CP MEDICAL 8682P-CP1 181227-54 10790986003559

    Patients

    Seq Age Sex Outcome Treatment
    1