BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND PLASTIC COMFORT FLEX BANDAGES

    MDR report key: 5014062 · Received August 19, 2015

    Report

    Report Number
    2214133-2015-00022
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 09-SEP-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 19-AUG-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2015 FROM A (B)(6)-YEAR-OLD MALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE REPORTED WEIGHT OF THE CONSUMER WAS (B)(6). ON (B)(6) 2015, THE CONSUMER USED (B)(4) BRAND PLASTIC COMFORT FLEX BANDAGES (LOT NUMBER 0125B, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, ONE BANDAGE, ONCE TO COVER A CUT ON LEG. ON THE SAME DAY, WHEN HE PULLED THE BANDAGE WHICH REMOVED A PIECE OF HIS SKIN FROM HIS LEG, IT STARTED TO BLEED AND HE VISITED EMERGENCY ROOM TO GET TWO STITCHES ON HIS LEG. THE DEVICE WAS NOT USED FURTHER. ON THE DAY OF REPORTING, HE STATED THAT THE BLEEDING HAD STOPPED BUT THE AREA APPEARED TO BE BRUISED AND PURPLE. THE EVENTS WERE RESOLVING. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-AUG-2015. A REVIEW OF THE DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. VISUAL INSPECTION WAS PERFORMED ON THE RETAIN SAMPLES AND ALL RESULTS MET SPECIFICATION. THE COATING BATCH RESULTS FOR ADHESIVE FORCE MET SPECIFICATION. THE ANALYSIS OF PRODUCT AND COMPLAINT CATEGORY WILL BE MANAGED THROUGH THE MONTHLY TRENDING PROCESS. THE PRODUCT MET SPECIFICATION AS DOCUMENTED IN THE RECORDS AND RETAIN SAMPLE REVIEW. BASED ON THE INVESTIGATION RESULTS, THERE IS NO EVIDENCE THAT A DEVICE MALFUNCTION OCCURRED. ACCORDING TO THE INFORMATION AVAILABLE, THE DEVICE WAS USED FOR AS INTENDED FOR TREATMENT. THIS IS THE FIRST COMPLAINT FOR COMPLAINT FOR ADHESIVE TOO STRONG FOR THIS LOT NUMBER OF (B)(4) BRAND PLASTIC COMFORT FLEX BANDAGES. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 24-JUL-2015 FROM A (B)(6) CAUCASIAN MALE CONSUMER REPORTING ON SELF FROM THE (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE REPORTED WEIGHT OF THE CONSUMER WAS (B)(6). ON (B)(6) 2015, THE CONSUMER USED BAND-AID BRAND PLASTIC COMFORT FLEX BANDAGES (LOT NUMBER 0125B, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, ONE BANDAGE, ONCE TO COVER A CUT ON LEG. ON THE SAME DAY, WHEN HE PULLED THE BANDAGE WHICH REMOVED A PIECE OF HIS SKIN FROM HIS LEG, IT STARTED TO BLEED AND HE VISITED EMERGENCY ROOM TO GET TWO STITCHES ON HIS LEG. THE DEVICE WAS NOT USED FURTHER. ON THE DAY OF REPORTING, HE STATED THAT THE BLEEDING HAD STOPPED BUT THE AREA APPEARED TO BE BRUISED AND PURPLE. THE EVENTS WERE RESOLVING. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547139 BAND-AID BRAND PLASTIC COMFORT FLEX BANDAGES ADHESIVE BANDAGE KGX SKILLMAN CONTRACT 8137005635 0125B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention