BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVERY BADGES SPACE ASSORTED FLEX FABRIC BANDAGES

    MDR report key: 13688943 · Received March 8, 2022

    Report

    Report Number
    3016050930-2022-00003
    Event Type
    Injury
    Date Received
    March 8, 2022
    Report Date
    March 7, 2022
    Manufacturer
    WELLY HEALTH PBC
    Product Code
    KGX
    UDI-DI
    00810010441003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER INFORMATION SUCH AS WEIGHT, AGE AND ETHNICITY WERE NOT PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE NOT RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION SINCE IT IS A SINGLE USE BANDAGE. DEVICE EVALUATION BY MANUFACTURER COULD THEREFORE NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN AS THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. IF ANY ADDITIONAL INFORMATION THAT WAS NOT AVAILABLE FOR THIS INITIAL MED-WATCH IS OBTAINED FROM THE PATIENT, AN ADDITIONAL MED-WATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ON 10-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER (AGE NOT PROVIDED) WHO TOPICALLY APPLIED BANDAGES FROM A WELLY BRAVERY BADGES UNICORN REFILL PACK (SEE ASSOCIATED MEDICAL DEVICE CASE 2022-US-003294) AND PACKAGE OF WELLY BRAVERY BADGES SPACE ASSORTED FLEX FABRIC BANDAGES. MEDICAL HISTORY INCLUDED AN ALLERGY TO LATEX AND RUBBER. THE REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING MEDICAL HISTORY AND CONCOMITANT PRODUCTS. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED IN TOTAL TWO TO THREE BANDAGES FROM THE WELLY BRAVERY BADGES UNICORN REFILL PACK AND WELLY BRAVERY BADGES SPACE ASSORTED FLEX FABRIC BANDAGES (LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED) TO HER ELBOW AT AN UNSPECIFIED FREQUENCY, DURATION OF APPLICATION, AND INDICATION. ON AN UNSPECIFIED DATE, AFTER THE CONSUMER APPLIED A COUPLE OF WELLY BRAVERY BADGES SPACE BANDAGES TO HER HANDS WITHOUT ISSUE, SHE THEN APPLIED THEM TO HER ELBOW. SHE SUBSEQUENTLY DEVELOPED SYMPTOMS OF REDNESS, INFLAMMATION, AND IRRITATION IN THE SHAPE OF THE BANDAGES WHERE THE ADHESIVE WAS ON HER ELBOW. SHE DID NOT HAVE ANY SYMPTOMS WHERE THE PAD OF THE BANDAGES WERE. SHE THEN TRIED BANDAGES FROM A WELLY BRAVERY BADGES UNICORN REFILL PACK AND HAD THE SAME SYMPTOMS. FOR TREATMENT SHE USED NEOSPORIN ON THE AREA, BUT IT DID NOT SEEM TO HELP. HER DOCTOR GAVE HER AN ANTI-BACTERIAL OINTMENT, WHICH SHE THOUGHT WAS BACTRIM (TRIMETHOPRIM & SULFAMETHOXAZOLE) IN-ORDER TO "CLEAN EVERYTHING UP." SHE APPLIES IT ON AT NIGHT AND COVERS IT WHILE SHE SLEEPS. SHE THOUGHT SHE MIGHT HAVE BEEN ALLERGIC TO THE GLUE OR SOMETHING IN THE PRODUCT CHANGED. AS OF 10-FEB-2022, THE STATUS OF THE CONSUMER'S SYMPTOMS WAS UNKNOWN. FURTHER INFORMATION IS NOT EXPECTED AS THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION. THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR WELLY HEALTH OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO WELLY HEALTH ACTUALLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337694 BRAVERY BADGES SPACE ASSORTED FLEX FABRIC BANDAGES ADHESIVE BANDAGES KGX WELLY HEALTH PBC WLY1061 00810010441003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention