BEUDAMED
    FDA Adverse Event Other Summary report: N

    NU-GEL COLLAGEN WOUND GEL

    MDR report key: 113015 · Received August 15, 1997

    Report

    Report Number
    1618732-1997-00179
    Event Type
    Other
    Date Received
    August 15, 1997
    Report Date
    August 15, 1997
    Manufacturer
    SWEEN CORP.
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE USED PRODUCT IN A PT'S WOUND AND THE PT COMPLAINED THAT IT "BURNED" WHEN THE PRODUCT WAS APPLIED. THEN WOUND BECAME RED AND INFLAMED OVER THE NEXT 2 DAYS WITH INCREASED DRAINAGE. THIS CAUSED A PHYSICIAN TO HAVE TO VISIT DAILY AND THE WOUND IS NOT RECOVERING WELL AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU-GEL COLLAGEN WOUND GEL DRESSING, SURGICAL WOUND MGQ SWEEN CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention
    2