BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSI-CARE STING FREE ADHESIVE RELEASER/REMOV

    MDR report key: 3763465 · Received April 9, 2014

    Report

    Report Number
    1000317571-2014-00019
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    August 22, 2013
    Report Date
    September 3, 2013
    Manufacturer
    CONVATEC LIMITED
    Product Code
    KOX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1049092-2013-00068.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT END-USER NEVER HAD SKIN BREAKDOWN OR BLISTERING, AND PRODUCT HAS BEEN DISCONTINUED FROM USE. FINAL QUALITY EVALUATION PERFORMED ON (B)(4) 2014, AND AN INVESTIGATION CONDUCTED BY THIRD PARTY SUPPLIER ON (B)(6) 2014 BASED ON THE REVIEW OF RETAINED SAMPLES AND QUALITY RECORDS. RESULTS FROM THE REVIEW WERE FOUND TO MEET SPECIFICATION. NO SAMPLE HAS BEEN PROVIDED FOR FURTHER INVESTIGATION. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR IRRITATION ISSUES. THE CHEMICALS IN THIS PRODUCT ARE INERT AND ARE USED FREQUENTLY IN SKIN CARE PRODUCTS, THE SUPPLIER BELIEVES THIS TO BE AN ISOLATED INCIDENT. NO FURTHER ACTION REQUIRED AS PER CONVATEC'S GOVERNING COMPLAINT HANDLING PROCEDURE. REPORTED TO THE FDA ON 04/08/2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC.'S COMPLAINT HANDLING AND CAPA PROCEDURES. PLEASE NOTE: THIS REPORT REPLACES INITIAL REPORT SUBMITTED ON 10/02/2013 UNDER PATIENT IDENTIFIER # 286172 AND MFR. REPORT # 1049092-2013-00068.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER SECOND USE THE SKIN BEGAN TO STING AND REDNESS OCCURRED. IT IS ALSO REPORTED THAT FOLLOWING THE REMOVAL OF THE WAFER, END-USER CHOSE NOT TO USE THE PRODUCT AND THE REDNESS IS NOW GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213344 SENSI-CARE STING FREE ADHESIVE RELEASER/REMOV SOLVENT, ADHESIVE TAPE KOX CONVATEC LIMITED 413499 131812017-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention