BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 6168487 · Received December 12, 2016

    Report

    Report Number
    9611959-2016-00003
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 14, 2016
    Manufacturer
    A.R. MEDICOM INC. (SHANGHAI) LTD.
    Product Code
    FXX
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS REPORTED TO (B)(4) ON (B)(6) 2016 FOR (B)(4) BRAND PRODUCT EARLOOP PROCEDURE MASK HIGH BARRIER TEAL ITEM CODE# 104-8819 LOT NUMBER #70421 WHICH WAS SOLD TO (B)(4). THE MASK IS CLASSIFIED AS A CLASS 2 DEVICE, UNDER FDA CODE FXX, 510K NUMBER K051291, WHOSE INTENDED USE IS TO BE WORN BY OPERATING ROOM PERSONNEL DURING SURGICAL PROCEDURES TO PROTECT BOTH THE SURGICAL PATIENT AND THE OPERATING ROOM PERSONNEL FROM TRANSFER OF MICROORGANISMS, BODY FLUIDS, AND PARTICULATE MATERIAL. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "PER FSC, THEY INDICATED THAT THE HYGIENIST HAD TROUBLE BREATHING WHILE USING THE MASK HOWEVER UPON (B)(4) CONVERSATION WITH HYGIENIST SHE DID NOT HAVE ANY TROUBLE BREATHING. (B)(6) 2016 (B)(4) LEFT MESSAGE FOR OFFICE. THEN ON (B)(6) 2016 (B)(6) SPOKE WITH (B)(6) WHO BROUGHT THE HYGIENIST, (B)(6) PERSON USING MASKS TO EMERGENCY ROOM SOON AFTER SHE HAD A RASH ON HER CHIN THAT WAS RED AND ITCHY THEN SPREAD TO THE REST OF HER BODY. SHE SAID THAT (B)(6) ALWAYS USES THESE TYPES OF MASKS AND DOES NOT HAVE ANY KNOWN ALLERGIES. THE REACTION WAS IMMEDIATE. AS OF TODAY (B)(6) IS DOING WELL. THESE ARE TYPICALLY STORED IN A CLOSET. THEN AT 12:02 P.M. (B)(4) RECEIVED PHONE CALL FROM (B)(6) . AS PER (B)(6) , SHE HAS BEEN USING THESE SAME TYPES OF MASKS FOR THE PAST SEVEN TO EIGHT YEARS AND HAS NEVER HAD AN ISSUE. IT SEEMED TO BE MORE RECENTLY THAT THE MASKS WERE MORE OF A TEAL COLOR AND HAD MORE OF AN UNPLEASANT SMELL ACCORDING TO (B)(6) . WHILE SHE WAS AT THE OFFICE SHE SAID SHE TOOK A BENADRYL THEN TAKEN TO THE EMERGENCY ROOM. WHILE SHE WAS AT THE EMERGENCY ROOM SHE WAS GIVEN I.V. MEDICATION, NOT BEING ABLE TO PROVIDE SPECIFICS BUT SHE SAID SHE WAS DISCHARGED THE SAME DAY. (B)(6) CONFIRMED THAT SHE HAD NO TROUBLE BREATHING ONLY A RASH THAT WAS RED AND ITCHY AND SPREAD TO OTHER PARTS OF HER BODY. (B)(6) SAID THAT SINCE THIS INCIDENT SHE AND THE REST OF THE STAFF HAVE SWITCHED TO ANOTHER TYPE OF MASK. SHE WAS ONLY PERFORMING A REGULAR CLEANING WHILE WEARING THESE MASKS." THE (B)(4) COMPLAINT RECEIVED BY (B)(4) HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER 2017-QACOM-175. (B)(4) INDICATED ON (B)(6) 2016 WHEN THE COMPLAINT WAS REPORTED THAT THEY WILL BE FILING A MEDWATCH WITH THE FDA FOR THIS ISSUE. ON (B)(6) 2016 A COPY OF THE INITIAL DRAFT OF THE MEDWATCH REPORT WAS RECEIVED FROM (B)(4). (REFER TO ATTACHED EMAIL DATED (B)(6)). THE FINAL VERSION OF THE MEDWATCH REPORT WAS RECEIVED FROM (B)(4) ON (B)(6)2016, AND IT WAS INDICATED THAT THE MDR WAS SUBMITTED TO THE FDA ON THAT SAME DAY (REFER TO ATTACHED EMAIL DATED (B)(6) 2016). IN PARALLEL, AN INVESTIGATION WAS PERFORMED BY THE MANUFACTURING FACILITY THROUGH CAPA-(B)(4) , AS FOLLOWS: INVESTIGATION: REVIEW OF AMD MEDICOM QUALITY COMPLAINT RECORDS CONFIRMED THAT NO SIMILAR ISSUES HAD BEEN REPORTED FOR ITEM CODE #104-8819, UNDER LOT #70421. REVIEW OF THE DEVICE HISTORY RECORD (PRODUCTION AND FINISHED PRODUCT PACKAGING RECORDS) AND APPLICABLE CHANGE CONTROL RECORDS CONFIRMED THAT THERE HAD BEEN NO CHANGES TO THE PRODUCT DESIGN, RAW MATERIALS, PACKAGING COMPONENTS AND/OR MANUFACTURING AND PACKAGING PROCESSES THAT WOULD IMPACT PRODUCT QUALITY A. ITEM CODE #104-8819 LOT #70421 WAS MANUFACTURED BETWEEN 06-JUN-2016 AND 07-JUN-2016 B. ALL RAW MATERIALS USED TO PRODUCE LOT #70421 WERE RELEASED WITHIN SPECIFICATION. RECENT CYTOTOXICITY TESTING PERFORMED ON RAW MATERIAL IN 2016 WERE IN COMPLIANCE WITH REQUIREMENT OF APPLICABLE STANDARD . C. CURRENT RAW MATERIAL SUPPLIER QUALIFIED. IN ADDITION, RAW MATERIAL SUPPLIER CONFIRMED THAT NO CHANGE OCCURRED IN THE MANUFACTURING PROCESS OF THE RAW MATERIAL. D. REVIEW OF THE EXECUTED PRODUCTION AND PACKAGING RECORDS FOR LOT 70421 CONFIRMED THAT THE FINISHED PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFIED INSTRUCTIONS. NO NONCONFORMANCE INCIDENTS WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. E. LOT #70421 WAS PACKAGED IN ACCORDANCE WITH THE SPECIFIED INSTRUCTIONS USING APPROVED PACKAGING COMPONENTS. F. THERE WAS NO CHANGE IN EQUIPMENT USED IN THE MANUFACTURING PROCESS. IN ADDITION, CLEANING AND MAINTENANCE WAS PERFORMED IN COMPLIANCE WITH CURRENT SOPS. G. PROPER HYGIENE WAS OBSERVED BY EMPLOYEES AS REQUIRED BY CURRENT SOP. H. STORAGE OF THE RAW MATERIAL AND FINISHED PRODUCT WAS PERFORMED IN COMPLIANCE WITH CURRENT SOP. I. NO CHANGE IN PERSONNEL. ALL EMPLOYEES TRAINING RECORDS ARE UP TO DATE AND ACCURATE. J. VISUAL EXAMINATION OF A RESERVE SAMPLE FOR LOT #70421 REVEALED THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. BASED ON THE RESULTS OF QUALITY INVESTIGATION, AMD MEDICOM CONCLUDED THAT THAT THE MASK ITEM CODE #104-8819 LOT #70421 WAS CONTRACT MANUFACTURED, PACKAGED, LABELED, TESTED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECIFICATIONS. NO EVIDENCE WAS IDENTIFIED THAT WOULD SUGGEST COMPROMISED PRODUCT QUALITY, EFFICACY OR SAFETY AT THE TIME OF RELEASE. IN CONCLUSION, THE HISTORY OF COMPLAINTS RECEIVED REGARDING SIMILAR ISSUES AND LITERATURE AND WEB-BASED RESEARCH, INDICATES THAT A CONTACT DERMATITIS TYPE RASH USUALLY DEVELOPS LOCALLY IN THE AREA OF THE BODY EXPOSED TO THE PRODUCT CAUSING THE ALLERGY.1 A SYSTEMIC RASH REACTION WOULD BE CAUSED BY AN EXAGGERATED IMMUNE RESPONSE AND THE RELEASE OF HISTAMINE IN THE BODY. THE ALLERGENIC SUBSTANCE WOULD NEED TO BE ABSORBED INTO THE BLOOD STREAM IN ORDER FOR A SYSTEMIC-LIKE REACTION TO OCCUR.2 IN THIS CASE, IT IS UNLIKELY THAT A SUBSTANCE FROM THE MASK WOULD BE ABSORBED THROUGH THE SKIN INTO THE BLOODSTREAM AND CAUSE A SYSTEMIC REACTION. THE SKIN IS A NATURAL BARRIER AND THE MASK IS EXPOSED TO THE SUPERFICIAL PORTION OF THE EPIDERMIS AND WOULD NOT USUALLY GET ABSORBED TO THE DERMIS OR SUBCUTANEOUS TISSUE. IT IS PROBABLE THAT A SYSTEMIC ALLERGIC REACTION AS DESCRIBED IN THE COMPLAINT COULD BE RELATED TO AN ALLERGY TO CERTAIN FOOD PRODUCTS CONSUMED OR TO A NEW MEDICATION USED BY THE COMPLAINANT. IN ADDITION, NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED FOR THIS PRODUCT AND LOT NUMBER. CONSEQUENTLY, AT THIS TIME, THE QUALITY COMPLAINT IS CONSIDERED ISOLATED AND POSSIBLY USER SPECIFIC; THEREFORE, NO FURTHER ACTION IS REQUIRED WITH RESPECT TO THIS COMPLAINT. 1) HTTP://PATIENT.INFO/HEALTH/CONTACT-DERMATITIS. 2) HTTP://MEDICAL-DICTIONARY.THEFREEDICTIONARY.COM/CONTACT+DERMATITIS.DISTRIBUTOR DID NOT RETURN DEVICE.

    Description of Event or Problem · 1

    ONE FEMALE HYGIENIST EXPERIENCED AN IMMEDIATE RED AND ITCHY RASH ON HER CHIN WHICH THEN SPREAD TO THE REST OF HER BODY. WHILE STILL AT THE DENTAL OFFICE SHE TOOK A BENADRYL THEN WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN I.V. MEDICATION. SHE WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818439 HENRY SCHEIN EXTRA PROTECTION EARLOOP MASK, PRODUCT CODE : FXX FXX A.R. MEDICOM INC. (SHANGHAI) LTD. 70421

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other