BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND AHESIVE BANDAGES FLEXIBLE FABRIC

    MDR report key: 5541931 · Received April 1, 2016

    Report

    Report Number
    8041154-2016-00002
    Event Type
    Injury
    Date Received
    April 1, 2016
    Report Date
    March 10, 2016
    Manufacturer
    BRAZIL CONSUMER
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 12-MAY-2016. THIS IS A FOLLOW UP SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8041154-2016-00002. THE MANUFACTURER REPORT NUMBER FOR THE SECOND, THIRD, FOURTH AND FIFTH PRODUCT IN THIS CASE ARE 8041154-2016-00003, 8041154-2016-00004, 8041154-2016-00005 AND 1000599868-2016-00002 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 01-APR-2016. THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THE SECOND, THIRD, FOURTH AND FIFTH PRODUCT IN THIS CASE ARE 8041154-2016-00003, 8041154-2016-00004, 8041154-2016-00005 AND 1000599868-2016-00001 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 10-MAR-2016 FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE MEDICAL HISTORY INCLUDED ALLERGY TO PENICILLIN. HE WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. ON AN UNSPECIFIED DATE, THREE DAYS AGO, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC CUTANEOUSLY, TWO BANDAGES TWO TIMES FOR SURGICAL WOUND DRESSING (LOT NUMBER 0435B AND EXPIRATION DATE UNSPECIFIED) AND BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE CUTANEOUSLY, ONE BANDAGE FOR SURGICAL WOUND DRESSING (LOT NUMBER 2834S AND EXPIRATION DATE UNSPECIFIED). HE ALSO USED AN UNSPECIFIED SURGICAL WASH TOPICALLY FOR THE WOUND (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, UPON REMOVAL OF THE BANDAGES, HIS SKIN CAME OFF. THE CONSUMER ALSO NOTICED ON THE SAME DAY, HIS SKIN DEVELOPED A THIRD DEGREE BURN, WHICH WAS OOZING AND BECAME BRIGHT RED. TO EASE THE EVENT, HE WASHED THE AREA WITH UNSPECIFIED SOAP AND WATER. ON AN UNSPECIFIED DATE, HE CONSULTED A DOCTOR WHO INDICATED THE EVENTS MAY BE DUE TO THE SURGICAL WASH USED. THE CONSUMER WAS STILL EXPERIENCING SYMPTOMS. THE ACTION TAKEN WITH BOTH THE DEVICES AND SURGICAL WASH WAS UNKNOWN. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-APR-2016 AND 29-APR-2016. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED FOR BOTH THE DEVICES. VISUAL INSPECTION AND PHYSICAL TESTING WAS PERFORMED ON THE RETAIN SAMPLES OF BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE (LOT NUMBER 2834S) AND ALL RESULTS MET SPECIFICATION. THE COMPLAINT INVESTIGATIONS FOR BOTH DEVICES WERE 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 (B)(6) 2016 FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE MEDICAL HISTORY INCLUDED ALLERGY TO PENICILLIN. HE WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. ON AN UNSPECIFIED DATE, THREE DAYS AGO, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC CUTANEOUSLY, TWO BANDAGES TWO TIMES FOR SURGICAL WOUND DRESSING (LOT NUMBER 0435B AND EXPIRATION DATE UNSPECIFIED) AND BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE CUTANEOUSLY, ONE BANDAGE FOR SURGICAL WOUND DRESSING (LOT NUMBER 2834S AND EXPIRATION DATE UNSPECIFIED). HE ALSO USED AN UNSPECIFIED SURGICAL WASH TOPICALLY FOR THE WOUND (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, UPON REMOVAL OF THE BANDAGES, HIS SKIN CAME OFF. THE CONSUMER ALSO NOTICED ON THE SAME DAY, HIS SKIN DEVELOPED A THIRD DEGREE BURN, WHICH WAS OOZING AND BECAME BRIGHT RED. TO EASE THE EVENT HE WASHED THE AREA WITH UNSPECIFIED SOAP AND WATER. ON AN UNSPECIFIED DATE, HE CONSULTED A DOCTOR WHO INDICATED THE EVENTS MAY BE DUE TO THE SURGICAL WASH USED. THE CONSUMER WAS STILL EXPERIENCING SYMPTOMS. THE ACTION TAKEN WITH BOTH THE DEVICES AND SURGICAL WASH WAS UNKNOWN. THE EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198544 BAND-AID BRAND AHESIVE BANDAGES FLEXIBLE FABRIC ADHESIVE BANDAGE KGX BRAZIL CONSUMER 8137004431 0435B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other