BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE

    MDR report key: 4216142 · Received October 31, 2014

    Report

    Report Number
    2214133-2014-00015
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    October 14, 2014
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 02-DEC-2014. THIS IS AN FOLLOW UP 1 SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2014-00015. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IS 2214133-2014-00016. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2014-00015. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IS 2214133-2014-00016.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)(4) 2014 FROM AN APPROXIMATELY (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED PERMANENT CHEST PORT INSERTION FOR CONTINUOUS SALINE INFUSIONS DUE TO LOW BLOOD VOLUME, LOW BLOOD PRESSURE, SEASONAL ALLERGIES, AND ALLERGIES MORPHINE AND CHAMOMILE. THE CONCOMITANT MEDICATIONS INCLUDED ZYRTEC (CETIRIZINE HYDROCHLORIDE) ONCE A DAY FOR SEASONAL ALLERGIES AND FLORINEF (FLUDROCORTISONE) FOR A YEAR AND A HALF FOR LOW BLOOD PRESSURE. ON AN UNSPECIFIED DATE, A FEW WEEKS AGO, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE (LOT NUMBER 1562B, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, ONE BANDAGE, CHANGED FOUR TO FIVE TIMES A DAY, APPLIED OVER THE OPEN CHEST PORT. SOMETIMES, THE CONSUMER APPLIED AN UNSPECIFIED NEOSPORIN (BACITRACIN, NEOMYCIN, AND POLYMYXIN B) (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED) UNDER THE BANDAGE. WITHIN A FEW DAYS, THE CONSUMER DEVELOPED RED WEEPING BLISTERS ON THE AREA WHERE THE BANDAGE WAS APPLIED. ON (B)(6) 2014, THE CONSUMER WENT TO THE EMERGENCY ROOM AND A BLOOD CULTURE WAS DONE. THE RESULT WAS NORMAL AND SHE WAS DIAGNOSED WITH CONTACT DERMATITIS. ON THE SAME DAY, SHE WAS GIVEN A ONE-TIME INJECTION OF ROCEPHIN (CEFTRIAXONE), AND WAS FURTHER PRESCRIBED WITH ORAL KEFLEX (CEPHALEXIN), BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) AND DOXYCYCLINE ALL THREE MEDICATIONS FOR 14 DAYS, AND LEVAQUIN (LEVOFLOXACIN) FOR THREE DAYS. SHE FURTHER SELF-MEDICATED AND APPLIED LOCAL HONEY (SIC) AND NEOSPORIN ON THE AFFECTED AREA TO TREAT THE EVENT AND DID NOT USE THE BANDAGE FURTHER. AFTER THE TREATMENT, THE EVENT RESOLVED AND HER SKIN RETURNED BACK TO NORMAL. AFTER AN UNSPECIFIED DURATION, THE CONSUMER STARTED TO USE CURAD GAUZE PAD TO COVER THE CHEST PORT AND APPLIED HONEY TO HELP THE GAUZE STICK WITH NO REACTIONS. AFTER AN UNSPECIFIED DURATION, SHE CONTINUED THE USE OF HONEY (SIC) TOPICALLY, AND SWITCHED TO JOHNSON AND JOHNSON FIRST AID STERILE GAUZE PADS (LOT NUMBER 3258A264, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, TO COVER THE CHEST PORT. THE CONSUMER WOULD CHANGE THE PAD SEVEN TIMES A DAY SINCE THE HONEY (SIC) DRIED AND DID NOT STAY ON HER SKIN. AFTER AN UNSPECIFIED DURATION, SIMILAR EVENTS OCCURRED, BUT DID NOT ESCALATE TO THE LEVEL OF THE BANDAGE. THE ACTION TAKEN WITH THE STERILE GAUZE PAD, NEOSPORIN AND HONEY (SIC) WAS UNKNOWN. THE CURRENT EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (INTERVENTION REQUIRED) AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 14-OCT-2014 FROM AN APPROXIMATELY (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED PERMANENT CHEST PORT INSERTION FOR CONTINUOUS SALINE INFUSIONS DUE TO LOW BLOOD VOLUME, LOW BLOOD PRESSURE, SEASONAL ALLERGIES, AND ALLERGIES MORPHINE AND CHAMOMILE. THE CONCOMITANT MEDICATIONS INCLUDED ZYRTEC (CETIRIZINE HYDROCHLORIDE) ONCE A DAY FOR SEASONAL ALLERGIES AND FLORINEF (FLUDROCORTISONE) FOR A YEAR AND A HALF FOR LOW BLOOD PRESSURE. ON AN UNSPECIFIED DATE, A FEW WEEKS AGO, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE (LOT NUMBER 1562B, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, ONE BANDAGE, CHANGED FOUR TO FIVE TIMES A DAY, APPLIED OVER THE OPEN CHEST PORT. SOMETIMES, THE CONSUMER APPLIED AN UNSPECIFIED NEOSPORIN (BACITRACIN, NEOMYCIN, AND POLYMYXIN B) (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED) UNDER THE BANDAGE. WITHIN A FEW DAYS, THE CONSUMER DEVELOPED RED WEEPING BLISTERS ON THE AREA WHERE THE BANDAGE WAS APPLIED. ON(B)(6) 2014, THE CONSUMER WENT TO THE EMERGENCY ROOM AND A BLOOD CULTURE WAS DONE. THE RESULT WAS NORMAL AND SHE WAS DIAGNOSED WITH CONTACT DERMATITIS. ON THE SAME DAY, SHE WAS GIVEN A ONE-TIME INJECTION OF ROCEPHIN (CEFTRIAXONE), AND WAS FURTHER PRESCRIBED WITH ORAL KEFLEX (CEPHALEXIN), BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) AND DOXYCYCLINE ALL THREE MEDICATIONS FOR 14 DAYS, AND LEVAQUIN (LEVOFLOXACIN) FOR THREE DAYS. SHE FURTHER SELF-MEDICATED AND APPLIED LOCAL HONEY (SIC) AND NEOSPORIN ON THE AFFECTED AREA TO TREAT THE EVENT AND DID NOT USE THE BANDAGE FURTHER. AFTER THE TREATMENT, THE EVENT RESOLVED AND HER SKIN RETURNED BACK TO NORMAL. AFTER AN UNSPECIFIED DURATION, THE CONSUMER STARTED TO USE CURAD GAUZE PAD TO COVER THE CHEST PORT AND APPLIED HONEY TO HELP THE GAUZE STICK WITH NO REACTIONS. AFTER AN UNSPECIFIED DURATION, SHE CONTINUED THE USE OF HONEY (SIC) TOPICALLY, AND SWITCHED TO JOHNSON AND JOHNSON FIRST AID STERILE GAUZE PADS (LOT NUMBER 3258A264, EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, TO COVER THE CHEST PORT. THE CONSUMER WOULD CHANGE THE PAD SEVEN TIMES A DAY SINCE THE HONEY (SIC) DRIED AND DID NOT STAY ON HER SKIN. AFTER AN UNSPECIFIED DURATION, SIMILAR EVENTS OCCURRED, BUT DID NOT ESCALATE TO THE LEVEL OF THE BANDAGE. THE ACTION TAKEN WITH THE STERILE GAUZE PAD, NEOSPORIN AND HONEY (SIC) WAS UNKNOWN. THE CURRENT EVENTS DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (INTERVENTION REQUIRED) AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 08-NOV-2014. A REVIEW OF THE DATA FOR BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE AND JOHNSON AND JOHNSON FIRST AID STERILE GAUZE PADS REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBERS. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. VISUAL INSPECTION WAS PERFORMED ON THE RETAINED SAMPLES AND ALL RESULTS MET SPECIFICATION. MANUFACTURING/FACILITY ISSUES WERE REVIEWED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED DEFECT. THE COMPLAINT INVESTIGATIONS WERE CLOSED FOR BOTH PRODUCTS WITH A DISPOSITION OF UNDETERMINED. THE ANALYSIS OF BOTH PRODUCTS AND COMPLAINT CATEGORIES WILL BE MANAGED THROUGH MONTHLY TRENDING PROCESS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS REPORT REMAINS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699903 BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC EXTRA LARGE ADHESIVE BANDAGE KGX SKILLMAN CONTRACT 8137005685 1562B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention