BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 375271 · Received January 25, 2002

    Report

    Report Number
    375271
    Event Type
    Injury
    Date Received
    January 25, 2002
    Date of Event
    December 24, 2001
    Report Date
    January 22, 2002
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MFR (GUIDANT) LEARNED OF POSSIBLE CONTAMINATION OF TWO LOTS (1112031 & 1112032) OF MULTI-LINK PENTA CORONARY STENTS ON 12/21/01. GUIDANT'S FIRST CONTACT WITH THE HOSP ABOUT A RECALL OF THE PRODUCT DID NOT OCCUR UNTIL THREE DAYS LATER, ON 12/24/01. BY THAT TIME ONE OF THE MEDICAL CENTER'S STENTS FROM THE INVOLVED LOT NUMBERS (1112031) HAD BEEN INSERTED IN A PT. FOUR OTHER STENTS WERE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA MULTI-LINK PENTA CORONARY STENT MAF GUIDANT VASCULAR INTERVENTION MULTI-LINK PENTA 3.0X8 1112031

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization 4 STENTS RETURNED TO MFR.