BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYBOND SUTURE

    MDR report key: 961770 · Received April 12, 2007

    Report

    Report Number
    3032563-2007-00001
    Event Type
    Other
    Date Received
    April 12, 2007
    Report Date
    November 2, 2006
    Manufacturer
    CP MEDICAL INC
    Product Code
    GAT
    PMA / PMN Number
    k001172
    Removal / Correction Number
    04/04/2007-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOTS WERE REVIEWED AND INSPECTED THAT WERE SEALED ON THE SAME SEALER (#A001) USING AQL SAMPLING: LOT #A0700920 - 0 DEFECTS, LOT #A0700930 - O DEFECTS, LOT# I0624740 - 0 DEFECTS, LOT# A0700920 - 1 - 0 DEFECTS, LOT# A0700310 - 1 - O DEFECTS. OF THE 2 AFFECTED LOTS: 0.33 (1/3) OF I0625120 HAD OPEN SEALS; 0.0135 (3/222) OF I0627120-1 HAD OPEN SEALS. PRODUCT WAS SHIPPED TO ONLY 1 CUSTOMER IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    PRODUCT HAS BEEN STERILIZED, BUT UNIT PACKAGE MAY HAVE OPEN SEALS. CUSTOMER RETURNED PRODUCT AND CP MEDICAL INSPECTED RETURNED PRODUCT AND IN-HOUSE PRODUCT, ON 2 LOTS PLUS AN ADDITIONAL LOT (FOR REF) PRODUCT RETURNED ON 01/30/07 (LOT # I0625120, I0627120-1) PRODUCT INSPECTION ON 02/19/07 (LOT # I0625120 - 248 OPEN SEALS OUT OF 744, LOT# I0627120 - 6 OPEN SEALS OUT OF 444, LOT # I0624740 - 0 OPEN SEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYBOND SUTURE NON-ABSORBABLE POLYESTER SUTURE GAT CP MEDICAL INC CP523A I0625120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other