BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 6665777 · Received June 23, 2017

    Report

    Report Number
    9611959-2017-00002
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Date of Event
    April 3, 2017
    Report Date
    June 19, 2017
    Manufacturer
    ALLMED MEDICAL PRODUCTS CO., LTD
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS REPORTED TO AMD MEDICOM INC. ON 06-APR-2017 FOR HENRY SCHEIN BRAND PRODUCT ADHESIVE BANDAGE SHEER STRIPS ITEM CODE# 112-6142 LOT NUMBER #71862. THE ADHESIVE BANDAGE IS CLASSIFIED AS A CLASS 1 DEVICE, UNDER FDA CODE (B)(4), WHOSE INTENDED USE IS TO COVER AND PROTECT WOUNDS, TO HOLD TOGETHER THE SKIN EDGES OF A WOUND, TO SUPPORT AN INJURED PART OF THE BODY, OR TO SECURE OBJECTS TO THE SKIN. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "PER SUE ITEM STICKS TO PATIENT VERY HARD PULLED OFF PATIENT SKIN, THE PATIENT WAS TREATED FOR OPEN WOUND, OTHERWISE PATIENT WAS FINE." SUBSEQUENTLY, ADDITIONAL INFORMATION WAS REQUESTED AND OBTAINED: ON 06-APR-2017 CLIENT WAS CONTACTED BY AMD MEDICOM BY EMAIL FOR FURTHER INFORMATION. ON 19-APR-2017 THE CLIENT RESPONDED BY FAX WITH THE COMPLETED QUESTIONNAIRE. THE PATIENT IS A (B)(6) MALE THAT WEIGHS APPROXIMATELY (B)(6) WHO USES THIS PRODUCT 3 TIMES A WEEK DURING HIS DIALYSIS TREATMENTS. THE PATIENT HAS A KNOWN ALLERGY TO PENICILLIN AND THE PATIENT HAD TO RECEIVE WOUND CARE FOR THE OPEN WOUND CAUSED WHEN THE PRODUCT WAS REMOVED FROM HIS SKIN." ALTHOUGH THE PATIENT STATED THAT HE USES THE PRODUCT 3 TIMES A WEEK DURING HIS DIALYSIS TREATMENTS, THIS IS THE ONLY COMPLAINT RECEIVED OF THIS NATURE AT THIS TIME FOR THIS PRODUCT. THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4). A REQUEST FOR INVESTIGATION WAS MADE TO THE MANUFACTURING FACILITY, THROUGH CAPA (B)(4). INVESTIGATION: -REVIEW OF AMD MEDICOM QUALITY COMPLAINT RECORDS CONFIRMED THAT NO SIMILAR ISSUES HAD BEEN REPORTED FOR ITEM CODE # 112-6142, UNDER LOT # 71862 OR SIMILAR PRODUCTS. -COMPLAINT SAMPLES WERE TESTED BY AMD MEDICOM. THE PRODUCT DID NOT PULL OFF THE SKIN OF THE INDIVIDUALS TESTED. -RETAIN SAMPLES WERE TESTED BY THE MANUFACTURING FACILITY AND NO ABNORMALITIES WERE FOUND. -INCOMING INSPECTION AND FINAL INSPECTION RECORDS WERE VERIFIED AND NO ABNORMALITIES WERE FOUND. PROBABLE ROOT CAUSE: -SINCE IT WAS REPORTED THAT THE END-USER UNDERGOES DIALYSIS 3 TIMES PER WEEK, THE NATURE OF THE COMPLAINT COULD POTENTIALLY BE RELATED TO PRE-EXISTING SKIN ABNORMALITIES THAT COULD BE PRESENT IN END STAGE RENAL DISEASE. THE PATIENT STATED THAT HE UNDERGOES DIALYSIS TREATMENT 3 TIMES PER WEEK. BASED ON THE NATIONAL KIDNEY FOUNDATION, DIALYSIS IS REQUIRED WHEN DEVELOPING END STAGE KIDNEY FAILURE (I.E. WHEN 85-90% OF KIDNEY FUNCTION IS LOST AND GFR (GLOMERULAR FILTRATION RATE) OF <15). -A CLINICAL REVIEWED ARTICLE DEMONSTRATED SIGNIFICANT DERMATOLOGIC MANIFESTATIONS OF END-STAGE RENAL DISEASE SUCH AS XEROSIS (DRY SKIN) AND ICHTHYOSIFORM SCALING DUE TO ATROPHY OF SEBACEOUS AND SWEAT GLANDS. ANOTHER ARTICLE INDICATED THAT OUT OF 102 PATIENTS WITH END-STAGE RENAL DISEASE, ALL HAD AT LEAST 1 FORM OF SKIN ALTERATION.1,2. -IF LEFT UNTREATED, XEROSIS (DRY SKIN) CAN LEAD TO COMPLICATIONS. FOR EXAMPLE, IF DRY SKIN PROMPTS ITCHING, INFLAMMATION AND BREAKS OR CRACKS IN THE SKIN THAT CAN LEAD TO A SECONDARY BACTERIAL INFECTION MAY RESULT. -ICHTHYOSIS CAUSES DRY AND SCALY SKIN. WHEN ICHTHYOSIS MAKES PIECES OF YOUR SKIN SCALE OFF, THE PROTECTIVE LAYER OF THE SKIN CAN SHED OFF AND LEAD TO POSSIBLE INFECTION. -THERE ARE A RANGE OF PRODUCTS ON THE MARKET TO PREVENT AND TREAT DRY SKIN BY RESTORING AND MAINTAINING SKIN HYDRATION SUCH AS BATH PRODUCTS, EMOLLIENTS, HYDRATING AGENTS, AND KERATIN-SOFTENING AGENTS. ANTIPRURITIC PRODUCTS, SKIN PROTECTANTS, AND TOPICAL HYDROCORTISONE ARE ALSO AVAILABLE TO PROTECT AREAS OF DRY SKIN AND TO RELIEVE INFLAMMATION, ERYTHEMA, AND ITCHING. A PROPER DAILY SKIN CARE REGIME IS IMPORTANT FOR INDIVIDUALS WITH MEDICAL CONDITIONS THAT COULD CAUSE THEM TO HAVE PROBLEMS WITH THEIR SKIN (I.E. END-STAGE RENAL DISEASE, DIABETES ETC.[?]). HEALTH CARE PROFESSIONALS SHOULD PROVIDE PATIENTS WITH KEY GUIDELINES IN THE TREATMENT, MANAGEMENT AND PREVENTION OF DRY SKIN. CORRECTIVE/PREVENTIVE ACTIONS: -A SKIN TEST WILL BE PERFORMED FOR EACH BATCH OF PRODUCT TO MONITOR AND EVALUATE ADHERENCE INTENSITY OF PRODUCT. -CONTINUED IMPLEMENTATION OF INCOMING INSPECTION OF ALL RAW MATERIALS TO ENSURE COMPLIANCE WITH REQUIRED INTERNAL STANDARD. BASED ON THE ABOVE EVALUATION, IT CAN BE REASONABLY CONCLUDED THAT DERMATOLOGICAL MANIFESTATIONS DUE TO CHRONIC RENAL FAILURE AND END-STAGE RENAL DISEASE MAY HAVE PREDISPOSED THE PATIENT TO HAVING MORE FRAGILE SKIN RESULTING IN THE SKIN BEING PULLED OFF WHEN THE ADHESIVE BANDAGE WAS REMOVED. ALTHOUGH THE PATIENT STATED THAT HE USES THE PRODUCT THREE (3) TIMES A WEEK DURING HIS DIALYSIS TREATMENTS, THIS IS THE ONLY COMPLAINT RECEIVED OF THIS NATURE AT THIS TIME FOR THIS PRODUCT. FURTHERMORE, INVESTIGATION OF THE MANUFACTURING PROCESS BY THE MANUFACTURING FACILITY CONCLUDED THAT THE PRODUCT MET ALL REQUIRED SPECIFICATIONS AND NO ABNORMALITIES WERE NOTED. REFERENCES: BREWSTER, URSULA C., MD. DERMATOLOGIC MANIFESTATIONS OF END-STAGE RENAL DISEASE. HOSPITAL PHYSICIAN MAY 2006; 31-35. PICO MR, LUGO-SOMOLINOS A, SANCHEZ JL, BURGOS-CALDERON R. CUTANEOUS ALTERATIONS IN PATIENTS WITH CHRONIC RENAL FAILURE. INT J DERMATOL 1992; 31:860-3. ITCHY, SCRATCHY SKIN: PREVENTING AND MANAGING XEROSIS - HTTP://WWW.PHARMACYTIMES.COM/PUBLICATIONS/ISSUE/2013/JUNE2013/ITCHY-SCRATCHY-SKIN-PREVENTING-AND-MANAGING-XEROSIS. WHAT IS ICHTHYOSIS? - HTTP://WWW.WEBMD.COM/SKIN-PROBLEMS-AND-TREATMENTS/WHAT-IS-ICHTHYOSIS?PRINT=TRUE. DIALYSIS. HTTPS://WWW.KIDNEY.ORG/ATOZ/CONTENT/DIALYSISINFO .

    Description of Event or Problem · 1

    A PATIENT WAS HAVING DIALYSIS TREATMENT AND WHEN THE TREATMENT WAS COMPLETED A BANDAGE WAS PLACED ON THE PATIENT'S ARM. WHEN TAKING OFF THE BANDAGE, THE PATIENT'S SKIN ADHERED TO THE BANDAGE. THE PATIENT WAS GIVEN WOUND CARE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443944 HENRY SCHEIN BANDAGE ADHESIVE SHEER STRIP KGX ALLMED MEDICAL PRODUCTS CO., LTD 71862

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other