BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 1211539 · Received October 3, 2008

    Report

    Report Number
    2522801-2008-00038
    Event Type
    Other
    Date Received
    October 3, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 3, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAR
    PMA / PMN Number
    K930825
    Removal / Correction Number
    Z00342009
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. ANGIOTECH REFERENCE: - (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LABEL ON THE BOX AND POUCH INDICATES SIZE 3-0, NYLON, BLACK MONOFILAMENT. HOWEVER, WHEN THE PRODUCT IS REMOVED FROM THE POUCH, THE CARD SHIELD IS LABELED AS SIZE 4-0 AND THE SUTURE INSIDE IS MADE OF (B) (4). THE PRODUCT WAS NOT USED ON A PATIENT. SAMPLES RETURNED TO ANGIOTECH WERE EVALUATED AND CONFIRMED THE CUSTOMER'S REPORT; POUCHES FROM LOT M335780 MISTAKENLY CONTAIN 4-0 (B) (4) SUTURE. FURTHER INVESTIGATION DETERMINED THAT ADDITIONAL PRODUCT FROM LOT M335780 IS AFFECTED. A FIELD CORRECTIVE ACTION WAS INITIATED ON 5-SEPTEMBER-2008 FOR ITEM (B) (4), LOT M335780.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK SUTURE WITH NEEDLE GAR SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) 925B M335780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other