BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243801-1999-00042

    MDR report key: 256870 · Received December 22, 1999

    Report

    Report Number
    2243801-1999-00042
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 1, 1999
    Report Date
    November 29, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETURN REASON: THE CUSTOMER REPORTED THAT THE BALLOON DID NOT DEFLATE AFTER TEST INFLATION. ANALYSIS DETERMINED: INVESTIGATION FOUND THAT THE BALLOON DEFLATED ACCEPTABLY BUT THAT THERE WAS A SMALL TEAR BELOW DISTAL ADHESIVE BAND OF BALLOON; ORIGIN UNKNOWN. NO MFG DEFECTS WERE FOUND. UNIT WAS USED IN VIVO. THIS WAS NOT DETERMINED UNTIL ANALYSIS WAS COMPLETED. NO FURTHER INFO IS AVAILABLE ON THE PT'S STATUS. CORRECTIVE ACTION TAKEN: THE CORRECTIVE ACTION IS THAT BBNJ IS CONTINUOUSLY WORKING TO IMPROVE ITS BALLOON LATEX TO LESSEN BALLOON TEARS. EACH BALLOON IS 100% INSPECTED, INFLATED AND DEFLATED PRIOR TO PACKAGING AND FINAL RELEASE. INSPECTION PROCESSES HAVE BEEN UPDATED AND ARE CONTINUALLY BEING EVALUATED FOR IMPROVEMENTS. BOTH THE FREQUENCY AND SEVERITY OF THIS TYPE OF INCIDENT WILL BE CLOSELY MONITORED TO DETERMINE IF FURTHER REMEDIAL ACTION IS NECESSARY.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other