BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH

    MDR report key: 15282721 · Received August 24, 2022

    Report

    Report Number
    1038758-2022-00034
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    July 26, 2022
    Report Date
    October 6, 2022
    Manufacturer
    EUROMED, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON (B)(6) 2022 MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF (B)(6) 2022 MANUFACTURER HAS NOT FINISHED THEIR INVESTIGATION. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 0

    THE INITIAL COMPLAINT BY THE CUSTOMER DID NOT INDICATE THAT AN MDR WOULD BE REQUIRED. HOWEVER, PER THE INFO RECEIVED ON 07/26/2022 MEDICAL TREATMENT WAS SOUGHT. BASED ON THE INFORMATION RECEIVED, ASO OPTED TO FILE AN MDR. AS OF 08/19/2022 MANUFACTURER HAS NOT FINISHED THEIR INVESTIGATION. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS. AS OF 10/04/2022 MANUFACTURER HAS COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. PLEASE REFERE TO B6 FOR DETAILS. THE FOLLOWING SECTIONS WERE UPDATED: B6; G6; H2; H3; H6 (TYPE OF INVESTIGATION; INVESTIGATION FINDINGS; INVESTIGATION CONCLUSIONS)

    Description of Event or Problem · 0

    ON THE INITIAL REPORT ON (B)(6) 2022 CONSUMER STATED THAT PRODUCT CAUSED A REACTION (BLISTERS) ON HER FOOT . ON COMPLETED CIR RECEIVED FROM CONSUMER ON (B)(6) 2022 SHE STATED APPLIED THE PRODUCT TO HER FOOT OVER A WART THAT HAD BEEN REMOVED. SHE ADDED SHE FELT PAIN AND THERE WAS A BLISTER. SHE WASHED THE AREA AND TRIED AGAIN AND GOT A SECOND BLISTER. CONSUMER STATED SOUGHT MEDICAL ATTENTION WITH A DERMATOLOGIST WHO PRESCRIBED CLOBETASOL PROPIONATE OINTMENT. THE CONSUMER STATED THE SYMPTOMS DID NOT IMMEDIATELY STOPPED AFTER DISCONTINUED USE OF THE PRODUCT, BUT IS SLOWLY GETTING BETTER (CONSUMER STILL HAD A BLISTER).

    Description of Event or Problem · 0

    ON THE INITIAL REPORT ON 07/12/2022 CONSUMER STATED THAT PRODUCT CAUSED A REACTION (BLISTERS) ON HER FOOT . ON COMPLETED CIR RECEIVED FROM CONSUMER ON 07/26/2022 SHE STATED APPLIED THE PRODUCT TO HER FOOT OVER A WART THAT HAD BEEN REMOVED. SHE ADDED SHE FELT PAIN AND THERE WAS A BLISTER. SHE WASHED THE AREA AND TRIED AGAIN AND GOT A SECOND BLISTER.CONSUMER STATED SOUGHT MEDICAL ATTENTION WITH A DERMATOLOGIST WHO PRESCRIBED CLOBETASOL PROPIONATE OINTMENT. THE CONSUMER STATED THE SYMPTOMS DID NOT INMEDIATELLY STOPPED AFTER DISCONTINUED USE OF THE PRODUCT, BUT IS SLOWLY GETTING BETTER (CONSUMER STILL HAD A BLISTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163789 CVS HEALTH ADVANCE HEALING HYDROCOLLOID BANDAGES NAD EUROMED, INC. UPC#050428373668 00151390

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other