BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI STRIP

    MDR report key: 1601002 · Received February 5, 2010

    Report

    Report Number
    1601002
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 5, 2010
    Manufacturer
    3M
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD PROSTATIC ROBOTIC SURGERY AND WAS ADMITTED. BLISTERS AROUND HIS LAP SITES ALTHOUGH HIS INCISION SITES WERE OK. THE BLISTERS BECAME WORSE AFTER DISCHARGE REQUIRING A VISIT TO THE SURGEON'S OFFICE TO HAVE THEM DRAINED. THE PATIENT RETURNED FOR ANOTHER PROCEDURE THE FOLLOWING WEEK WITH CONCERNS REGARDING WHAT MAY HAVE CAUSED THE BLISTERS. THE SURGEON'S OFFICE STATED THEY BELIEVED THE BLISTERS WERE AN ALLERGIC REACTION TO THE STERI STRIPS. THE PATIENT WILL LIST STERI STRIPS AS AN ALLERGY IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI STRIP TAPE, SKIN CLOSURE FPX 3M UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R