BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-STRIP SKIN CLOSURES (REINFORCED)

    MDR report key: 2090001 · Received May 5, 2011

    Report

    Report Number
    2110898-2011-00051
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 7, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - TESTING NOT PERFORMED. RESULTS - PRODUCT NOT RETURNED. CONCLUSIONS - NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A SURGICAL MATERIAL, SERVICES PROFESSIONAL AT (B)(6) IN (B)(6) CONTACTED (B)(6) TO REPORT BLISTERING ASSOCIATED WITH MASTISOL LIQUID ADHESIVE. THE REPORTER INDICATED THAT THERE WERE FOUR PTS THAT HAD EXPERIENCED BLISTERING FOLLOWING THE USE OF MASTISOL LIQUID ADHESIVE AND STERI-STRIPS. THE SKIN REACTIONS ARE BEING IDENTIFIED DURING THE PTS' POST-OP VISITS UPON REMOVAL OF THE STERI-STRIPS. THE POST-OP VISITS TYPICALLY OCCUR BETWEEN 2-7 DAYS, FOLLOWING A SURGERY. THE SKIN REACTION INCLUDED A RASH AND BLISTERS, FOR THE PT IN THIS COMPLAINT, WHICH OCCURRED POST A HYSTERECTOMY PROCEDURE. THIS PT WAS TREATED WITH A PRESCRIPTION STEROID AND IT HAS BEEN REPORTED THAT THE PT IS HEALING FINE. ADDITIONAL MEDICAL DATE: (B)(6) 2011. (INFORMATION THAT MADE THIS COMPLAINT REPORTABLE WAS NOT PROVIDED TO 3M UNTIL (B)(6) 2011).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-STRIP SKIN CLOSURES (REINFORCED) 880.5240 MEDICAL ADHESIVE TAPE & BANDAGE FPX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other