BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND

    MDR report key: 10025613 · Received May 5, 2020

    Report

    Report Number
    8041154-2020-00012
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    June 21, 2017
    Report Date
    June 26, 2017
    Manufacturer
    BRAZIL CONSUMER
    Product Code
    KGX
    UDI-DI
    00381370057055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO SUBMISSION 8041154-2017-00005 ¿ 1: UPON RECEIPT OF E-MAIL NOTIFICATION FROM THE FDA MEDWATCH PROGRAM ON 30-APR-2020, A REVIEW OF SUBMISSION 8041154-2017-00005 ¿ 1 WAS CONDUCTED. UPON THIS REVIEW, IT WAS CONFIRMED THAT TYPE OF REPORT WAS SUBMITTED AS AN INITIAL AND A FOLLOW-UP REPORT AND THAT 8041154-2017-00005 WAS SUBMITTED ON-TIME, PASSING ALL ACKNOWLEDGEMENTS. EMDR 8041154-2017-00005 WAS INTENDED TO BE SUBMITTED AS AN INITIAL REPORT; TYPE OF REPORT HAS BEEN CORRECTED. HOWEVER, DUE TO COMPLAINT HANDLING SYSTEM UPGRADES THE ORIGINAL EMDR MANUFACTURING NUMBER SUBMISSION 8041154-2017-00005 ¿ 1 COULD NOT BE REVISED, THEREFORE A NEW EMDR WAS CREATED AS EMDR MANUFACTURING NUMBER 8041154-2020-00012 TO CAPTURE THIS EVENT AGAIN FOR INITIAL SUBMISSION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2017 FROM A MALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE MEDICAL HISTORY OF THE CONSUMER INDICATED PROSTHETIC LEG. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING BAND AID BRAND CUTANEOUSLY EVERY NIGHT TO COVER A WOUND (LOT NUMBER 3084B, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER NOTICED THAT THE GAUZE SEPARATED FROM THE ADHESIVE AND STUCK ON SKIN DUE TO WHICH CONSUMER REPORTED THAT HE MAY HAVE DEVELOPED POTENTIAL INFECTION AT APPLICATION SITE WHICH CONSUMER DESCRIBED AS IT MAY BE LIFE THREATENING INFECTION AND STATED AS POTENTIAL LOSS OF LIFE. ON AN UNSPECIFIED DATE, ON FRIDAY, HE WENT TO EMERGENCY ROOM FIRST TIME AND ON (B)(6) 2017 HE WENT TO EMERGENCY ROOM SECOND TIME AND CONSULTED THE PHYSICIAN. THE ACTION TAKEN WITH THE DEVICE AND OUTCOME OF THE EVENT WERE UNKNOWN. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS NON-SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS NOT RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-JUL-2017. THIS REGULATORY AUTHORITY REPORT WAS RECEIVED ON 11-JUL-2017 FROM FDA (FOOD AND DRUG ADMINISTRATION) (ADVERSE EVENT REPORTING NUMBER MW5070683_2). THE MEDICAL HISTORY OF THE CONSUMER INCLUDED RIGHT LEG AMPUTEE, RIGHT PROSTHETIC LEG AND SCAR. THE CONCOMITANT MEDICATION INCLUDED ASPIRIN, CARVEDILOL, CRESTOR (ROSUVASTATIN), LISINOPRIL AND METFORMIN ALL FOR UNKNOWN INDICATION. ON AN UNSPECIFIED DATE IN (B)(6) 2017, THE CONSUMER STATED USING THE DEVICE ONE BANDAGE ONE TIME FOR WOUND PROTECTION OF RIGHT LEG. ON (B)(6) 2017, THE CONSUMER NOTICED THAT THE FOAM SEPARATES FROM THE ADHESIVE, FOUND IT ON THE EDGE OF THE BED WHICH DESCRIBED AS BANDAGE WAS MISSING LIKE IT DISSOLVED. THE BANDAGE ADHESIVE SEPARATED FROM THE SKIN AND THE FOAM, LEFT WOUND OPEN AND THE ADHESIVE JUST LIKE A PIECE OF PAPER. IT WAS REPORTED THAT THE CONSUMER DEVELOPED REDNESS AND CONSUMER THOUGHT THAT GOT INFECTION. ON AN UNSPECIFIED DATE, THE CONSUMER WENT TO AN EMERGENCY ROOM FIRST TIME WHERE DOCTOR DID NOT THINK THAT THE CONSUMER GOT INFECTION. THE CONSUMER SECOND TIME WENT AN EMERGENCY ROOM BUT DID NOT HAVE AN INFECTION. AFTER AN UNSPECIFIED DURATION, THE CONSUMER USED ANOTHER BOX OF SAME BANDAGE AND EXPERIENCED SAME EVENT. THE OUTCOME THE EVENT REDNESS WAS UNKNOWN. A REVIEW OF THE DATA REVEALED NO UNFAVORABLE TRENDS FOR THE REPORTED LOT NUMBER. THE ANALYSIS FOR THE PRODUCT COMPLAINT CATEGORY WILL BE MANAGED THROUGH MONTHLY TRENDING PROCESS. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS (LIFE THREATENING AND OTHER MEDICALLY IMPORTANT EVENT). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 07-SEP-2017. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED. PRODUCT MET SPECIFICATION AS DOCUMENTED IN THE RECORDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THE CASE REMAINS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488895 BAND AID BRAND ADHESIVE BANDAGE KGX BRAZIL CONSUMER 3084B 00381370057055

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O