BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENROSE DRAIN

    MDR report key: 5105 · Received June 11, 1993

    Report

    Report Number
    5105
    Event Type
    Malfunction
    Date Received
    June 11, 1993
    Date of Event
    April 12, 1993
    Report Date
    May 17, 1993
    Manufacturer
    DAVOL
    Product Code
    HFL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PENROSE DRAINS REMOVED. ONE SIDE CAME OUT IN PIECES; PATIENT HAD SURGERY TO REMOVE PENROSE PIECES.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION EXAMINATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENROSE DRAIN Implant PENROSE DRAIN HFL DAVOL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other