BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND ADHESIVE BANDAGES CLEAR WATER BLOCK PLUS®

    MDR report key: 3376383 · Received September 30, 2013

    Report

    Report Number
    8041154-2013-00011
    Event Type
    Injury
    Date Received
    September 30, 2013
    Date of Event
    August 23, 2013
    Report Date
    September 2, 2013
    Manufacturer
    BRAZIL CONSUMER
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 11-NOV-2013. 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) 2013 FROM A (B)(6) CAUCASIAN MALE PARAMEDIC REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED UNSPECIFIED HEART DISORDER, HIGH BLOOD PRESSURE, ABNORMAL BLOOD CHOLESTEROL, DIABETES AND ALLERGY TO ADHESIVES. THE CONCOMITANT MEDICATIONS INCLUDED RIVAROXABAN DAILY FOR ANTICOAGULANT- HEART CONDITION FOR APPROXIMATELY A YEAR. ON (B)(6) 2013, BEFORE GOING TO BED, THE CONSUMER STARTED USING (B)(6) BRAND ADHESIVE BANDAGES CLEAR WATER BLOCK PLUS, CUTANEOUSLY ONE BANDAGE AT A TIME TO COVER A CUT ON LEFT FOREARM AND FOR WOUND PROTECTION (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE NEXT MORNING, HE NOTICED REDNESS AND SWELLING ON HIS FOREARM AND HE EXPERIENCED ITCHING. HE ALSO NOTICED AN OUTLINE OF THE BANDAGE ON THE SKIN OF HIS FOREARM. HE WENT TO THE DOCTOR WHO ADVISED HIM TO GO TO AN EMERGENCY ROOM TO GET AN UNSPECIFIED INTRAVENOUS (IV) TREATMENT, BUT HE DID NOT GO. THE EVENT WAS TREATED BY AN UNSPECIFIED ANTIBIOTIC. HE STATED THAT THE AREA ON HIS FOREARM WAS RECOVERING FROM THE EVENT AND SWELLING SUBSIDED. HE EXPERIENCED SIMILAR EVENTS IN THE PAST WITH AN UNSPECIFIED ADHESIVES AND DISSOLVING SUTURES. HE ALSO MENTIONED THAT THE EVENTS WERE NOT RELATED TO THE DEVICE. AFTER TWELVE DAYS, THE USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS WERE RESOLVING. THE REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) CAUCASIAN MALE PARAMEDIC REPORTING ON SELF FROM THE (B)(6). THE MEDICAL HISTORY INCLUDED UNSPECIFIED HEART DISORDER, HIGH BLOOD PRESSURE, ABNORMAL BLOOD CHOLESTEROL, DIABETES AND ALLERGY TO ADHESIVES. THE CONCOMITANT MEDICATIONS INCLUDED RIVAROXABAN DAILY FOR ANTICOAGULANT- HEART CONDITION FOR APPROXIMATELY A YEAR. ON (B)(6) 2013, BEFORE GOING TO BED, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES CLEAR WATER BLOCK PLUS, CUTANEOUSLY ONE BANDAGE AT A TIME TO COVER A CUT ON LEFT FOREARM AND FOR WOUND PROTECTION (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE NEXT MORNING, HE NOTICED REDNESS AND SWELLING ON HIS FOREARM AND HE EXPERIENCED ITCHING. HE ALSO NOTICED AN OUTLINE OF THE BANDAGE ON THE SKIN OF HIS FOREARM. HE WENT TO THE DOCTOR WHO ADVISED HIM TO GO TO AN EMERGENCY ROOM TO GET AN UNSPECIFIED INTRAVENOUS (IV) TREATMENT, BUT HE DID NOT GO. THE EVENT WAS TREATED BY AN UNSPECIFIED ANTIBIOTIC. HE STATED THAT THE AREA ON HIS FOREARM WAS RECOVERING FROM THE EVENT AND SWELLING SUBSIDED. HE EXPERIENCED SIMILAR EVENTS IN THE PAST WITH AN UNSPECIFIED ADHESIVES AND DISSOLVING SUTURES. HE ALSO MENTIONED THAT THE EVENTS WERE NOT RELATED TO THE DEVICE. AFTER TWELVE DAYS, THE USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS WERE RESOLVING. THE REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION RECEIVED ON 23-OCT-2013: A REVIEW OF THE COMPLAINT DATA REVEALED NO SIGNIFICANT ADVERSE TRENDS. SINCE A VALID LOT NUMBER WAS NOT PROVIDED, NO FURTHER INVESTIGATION COULD BE CARRIED OUT. THE COMPLAINT COULD NOT BE CONFIRMED BASED ON AN ACCEPTABLE SITE REVIEW AND NO ADVERSE TRENDS. ROOT CAUSE AND DISPOSITION WERE UNDETERMINED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491540 BAND-AID BRAND ADHESIVE BANDAGES CLEAR WATER BLOCK PLUS® ADHESIVE BANDAGE KGX BRAZIL CONSUMER 8137005659 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other