BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION HEALTHCARE PRODUCTS

    MDR report key: 354969 · Received October 5, 2001

    Report

    Report Number
    MW1023020
    Event Type
    Malfunction
    Date Received
    October 5, 2001
    Date of Event
    September 19, 2001
    Report Date
    September 25, 2001
    Manufacturer
    TRI-STATE HOSPITAL SUPPLY CORP
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/29/01: INVESTIGATION: THE SAMPLE WAS NOT SAVED, AND THEREFORE COULD NOT BE EXAMINED. THE LOT NUMBER, 00343, WAS ABLE TO BE IDENTIFIED VIA A PHONE CONVERSATION WITH THE RISK MGR FROM HOSP. AN INITIAL NOTIFICATION WAS SENT TO THE MFR, RAPID AID, ON 11/2/01 AND A FOLLOW-UP LETTER IDENTIFYING THE LOT NUMBER WAS SENT ON 11/12/01. THERE WAS NO STOCK REMAINING OF LOT 00343. THE VENDOR FORWARDED INFO REGARDING SKIN IRRITATION TESTS PERFORMED ON THE PRODUCT AND THE CURRENT MSDS DID NOT RECEIVE A PERMANENT OR LIFE THREATENING INJURY. THE MFR PRODUCED 469 CASES UNDER LOT 00343 ON 12/8/00. INSPECTION RECORDS WERE FORWARDED FOR REVIEW, AND NO DISCREPANCIES OR PRODUCT FAILURES WERE OBSERVED DURING THE PRODUCTION. A WRITTEN RESPONSE WAS RECEIVED ON 11/21/01. A TOTAL OF 125 CP24 UNITS (RANDOMLY SAMPLED FROM STOCK ON HAND) WERE ACTIVATED, CHECKED FOR LEAKAGE, RE-PACKED INTO THE ORIGINAL CARTON FOR TWO HRS, AND THEN RE-INSPECTED AGAIN FOR SIGNS OF LEAKAGE. NO BREAKAGE/LEAKS WERE OBSERVED IN THE UNITS TESTED. THE VENDOR HAS ALSO REVIEWED COMPLAINT HISTORY, FOR WHICH THEY HAVE RECEIVED FORMAL NOTIFICATION OF THREE OCCURRENCES WITHIN THE PAST 12 MOS. AT THIS TIME, RAPID AID HAS NOT BEEN ABLE TO CORRELATE PRODUCT COMPLAINTS WITH PRODUCTION DATES, LOT NUMBERS, RAW MATERIALS, STORAGE, OR HANDLING.

    Description of Event or Problem · 1

    COOL PERI-PAD LEAKED WHILE IN USE BY PT RESULTING IN A BURNING, WARM SENSATION TO PERINEUM AND BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45311 CENTURION HEALTHCARE PRODUCTS COLL PERI-PAD IMD TRI-STATE HOSPITAL SUPPLY CORP * 7136-8

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other