BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRESSING PRIMAPORE 2"X3"

    MDR report key: 11693181 · Received April 19, 2021

    Report

    Report Number
    MW5100861
    Event Type
    Injury
    Date Received
    April 19, 2021
    Report Date
    April 14, 2021
    Manufacturer
    UNK
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REPORTS HAVING REACTION TO PRIMAPORE DRESSING - REDNESS / IRRITATION. NO FURTHER INFO PROVIDED. PRESCRIBER REMS ID: (B)(6); PT REMS ID: (B)(6), UNK IF MD AWARE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581095 DRESSING PRIMAPORE 2"X3" TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1