BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSI-CARE PROTECTIVE BARRIER

    MDR report key: 4023614 · Received August 14, 2014

    Report

    Report Number
    1049092-2014-00400
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Product Code
    NEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, IT WAS CONFIRMED THE THIRD PARTY MANUFACTURER FOR THIS PRODUCT WAS APEX. THE CORRECTION HAS BEEN MADE BELOW. AN INVESTIGATION WAS PERFORMED BY APEX THAT CONSISTED OF A REVIEW OF 10 LOT BATCH RECORDS. MICRO TESTING WAS PREVIOUSLY PERFORMED ON BULK, AS WELL AS AT THE BEGINNING OF EACH SHIFT AND END OF EACH SHIFT WITH EACH SAMPLE MEETING SPECIFICATION REQUIREMENTS. COMPOUNDING, FILLING, INVESTIGATION, DEVIATION AND OUT-OF-SPECIFICATION RECORDS WERE REVIEWED WITH NO RELEVANT FINDINGS NOTED. THE RETAIN REVIEW WAS COMPLETED FOR ALL TEN LOTS. SAMPLES FROM THROUGHOUT THE RUNS WERE REVIEWED BY QUALITY PERSONNEL FOR SIGNS OF DETERIORATION AND INDICATIONS OF CONTAMINATION (LEAKAGE, BULGING/DISTORTED PACKAGES, ETC.) WITH NO RELEVANT OBSERVATIONS NOTED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. THIRD PARTY MANUFACTURER: APEX INTERNATIONAL, 134 COLUMBIA COURT, CHASKA, MINNESOTA 55318 USA.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR THE EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE ARE THREE (3) CASES ASSOCIATED WITH THIS PRODUCT, THEREFORE A SEPARATE FDA 3500A FORM HAS BEEN GENERATED TO ADDRESS THE OTHER TWO (2) CASES. THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. PRODUCT THERAPEUTIC INDICATIONS ARE TO TEMPORARILY PROTECT AND HELP RELIEVE CHAPPED OR CRACKED SKIN AND LIPS; TO TREAT AND PREVENT DIAPER RASH; AND PROTECT MINOR SKIN IRRITATION ASSOCIATED WITH DIAPER RASH AND TO HELP SEAL OUT WETNESS. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. REPORTED TO THE FDA ON AUGUST 14, 2014.

    Description of Event or Problem · 1

    REJECTED BY AXC4 TO CONFIRM DRUG OR DEVICE. THE FACILITY WOUND CARE MANAGER REPORTED THAT THREE (3) PATIENT DEVELOPED PRESSURE ULCERS TO THE SACRA-BUTTOCK AREA. THE WOUND CARE MANAGER STATED THE PRODUCT WAS BEING UTILIZED FOR CONTACT DERMATITIS IN THE SACRAL AREA DN THE NURSES WERE APPLYING THE PROTECTIVE BARRIER TO WET MOIST AREAS. THE DEPTH OF THE PRESSURE ULCERS WERE ASSESSED AS STAGE III OR STAGE IV ALTHOUGH IT WAS REPORTED THE STAFF WERE HAVING DIFFICULTY REMOVING THE PRODUCT AND WERE UNABLE TO ASSESS THE SKIN. THE WOUND CARE MANAGER DID NOT INDICATE ADDITIONAL TREATMENT FOR THE PRESSURE ULCERS. THE TERRITORY MANAGER INDICATED THE FACILITY HAD ELECTED TO SWITCH TO A NEW PRODUCT AND WERE ADVISED THEY HAD TO USED THE PRODUCT IN STOCK BEFORE SWITCHING TO THE NEW PRODUCT. HE REPORTED NO SAFETY ISSUES WAS INVOLVED, HOWEVER EDUCATIONAL OPPORTUNITIES FOR THE APPLICATION OF PRODUCT, HOW TO ASSESS SKIN, AND REAPPLICATION OF THE PRODUCT WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382040 SENSI-CARE PROTECTIVE BARRIER TOPICAL, 4 OUNCE SIZE; QUANTITY PER CASE: 24 TUBES NEC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O