BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMOVE 8.0 OZ BOTTLE 01

    MDR report key: 12972106 · Received December 9, 2021

    Report

    Report Number
    8043484-2021-02006
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    November 19, 2021
    Report Date
    March 7, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KOX
    UDI-DI
    00040565112435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION, ALL SUPPLIED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO CONFIRM THE COMPLAINT. MEDICAL REVIEW CONCLUDE, THE COMPLAINT DETAILS, REPRESENTS A PROCEDURE COMPLICATION AND DOES NOT REPRESENT A DEVICE MALFUNCTION. IT IS UNKNOWN IF THE DIRECTION FOR USE OF THE REMOVE 8.0 OZ BOTTLE 01 WAS ADHERED TO. THE REMOVE IS FLAMMABLE USE IN A WELL-VENTILATED AREA. WASH THE PATIENT¿S SKIN WITH SOAP, WATER AND THEN PAT DRY.¿ ACCORDING TO THE REPORT, THIS EVENT WAS ADDRESSED BY WOUND CARE CONSULT. HOWEVER, SINCE THIS ISSUE WAS UNRESOLVED, THE IMPACT TO THE PATIENT BEYOND THAT WHICH ALREADY BEEN REPORTED IS UNKNOWN. SHOULD ANY ADDITIONAL RELEVANT PATIENT INFORMATION BE PROVIDED, THIS COMPLAINT WOULD BE RE-ASSESSED. A PROBABLE ROOT CAUSE MAY INCLUDED PATIENTS SENSITIVITY TO THE PRODUCT. A DOCUMENTATION REVIEW HAS BEEN CONDUCTED, CONFIRMING NO PREVIOUS COMPLAINTS OF THIS NATURE AND NO HISTORICAL ESCALATIONS HAVE BEEN OBSERVED. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT NO MANUFACTURING PROBLEMS WHERE OBSERVED. THE INSTRUCTIONS FOR USE CONTAIN COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE RISK FILES MITIGATE THE REPORTED ISSUE WITH NO UPDATES REQUIRED. THIS INVESTIGATION IS NOW COMPLETE, WITH NO MANUFACTURING PROBLEMS OBSERVED, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY. SMITH AND NEPHEW CAN CONFIRM THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS AND CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING WOUND TREATMENT, ONE PATIENT EXPERIENCED BURNS WHEN USING REMOVE. IT IS USED THE ADHESIVE REMOVER, CHLORHEXIDINE, THEN CHLORAPREP, AND THE BURN IS ON THE SIDE OF THE PATIENT WHERE THIS MIGHT HAVE POOLED. A PAD THAT CIRCULATES HEATED WATER TO HELP WITH BODY TEMPERATURE DURING THE HEART SURGERY IS ALSO LAID. IT IS UNKNOWN HOW THIS EVENT HAS BEEN ADDRESSED. PATIENT OUTCOME IS ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865321 REMOVE 8.0 OZ BOTTLE 01 SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW MEDICAL LTD. 403300 UNK 00040565112435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown