BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M MEDIPORE + PAD SOFT CLOTH DRESSING

    MDR report key: 1953432 · Received December 30, 2010

    Report

    Report Number
    2110898-2010-00158
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (TESTING NOT PERFORMED). RESULTS: (PRODUCT NOT RETURNED). CONCLUSIONS: (NO EVAL WILL BE PERFORMED).

    Description of Event or Problem · 1

    NURSE STATED THAT STERI-STRIPS WERE APPLIED TO A C-SECTION INCISION WHICH WAS COVERED BY A DRESSING. THE PT COMPLAINED OF ITCHING AND A RED RASH WAS NOTED UNDER THE DRESSING. THE PHYSICIAN PRESCRIBED TRIAMCINOLONE CREAM TO RELIEVE SYMPTOMS. THE PT HAD A SLIGHT FEVER. THE AREA WAS CLEANSED AND AN OPSITE DRESSING WAS APPLIED. NO FURTHER MEDICAL CARE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M MEDIPORE + PAD SOFT CLOTH DRESSING 880.5240 MEDICAL ADHESIVE TAPE & BANDAGE KGX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other TRIAMCINOLONE OINTMENT