BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-STRIP WOUND CLOSURES

    MDR report key: 1640034 · Received March 18, 2010

    Report

    Report Number
    2110898-2010-00028
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 22, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING STATES THE EXPECTED AES WITH PRODUCT USE IN THE WARNING SECTION SHOWN BELOW. WARNINGS: THE DEVELOPMENT OF POSTOPERATIVE EDEMA MAY CAUSE SKIN SHEARING, SKIN BLISTERING, OR LOSS OF TAPE ADHESION TO OCCUR AT EITHER END OF THE STRIP. APPLICATION OF ANY SURGICAL TAPE OR ADHESIVE SKIN CLOSURE MAY RESULT IN SKIN STRIPPING UPON REMOVAL. AS WITH ALL ADHESIVE PRODUCTS APPLIED TO THE SKIN, A SMALL PERCENTAGE OF INDIVIDUALS MAY EXPERIENCE HYPOPIGMENTATION OR HYPERPIGMENTATION FOLLOWING REMOVAL. OCCASIONAL CASES OF MILD ACNE AND FOLLICULITIS HAVE BEEN OBSERVED IN TESTING ON HEALTHY VOLUNTEERS.

    Description of Event or Problem · 1

    THE PATIENT HAS 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 WOUND CLOSURES TAPE, SKIN CLOSURE FPX 3M HEALTH CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention