CHEWIES (TM) ALIGNER TRAY SEATERS DS¿ PINK BG 150PK

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION FROM THE ALLEGED USE OF CHEWIES (TM) ALIGNER TRAY SEATERS DS¿ PINK BG 150PK.

Additional Manufacturer Narrative

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE : DHR (B)(6) 2023: DHR FOR ITEM# AC150PBGDS CHEWIES (TM) ALIGNER TRAY SEATERS DS¿ PINK 150PK BATCH# 05814287 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT IDENTIFY ANY ISSUES DURING THE EXTRUSION AND PACKAGING PRODUCTION ORDER. ALL INSPECTIONS WERE PERFORMED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER 0290-PS-PKG-AC, 0290-WSS-7.5-50-07 & 0290-IP-7.5-31-02. THE BOM FOR ITEM# AC150PBGDS CALL FOR 3 DIFFERENT RAW MATERIALS WHICH ARE GNLR (GLENROE NON LATEX RAW MATERIAL), BUBBLEGUM (306-110 BUBLEGUM) AND TB PINK (POWDER COLOR 006807RDEVC MC-34140EV). RECEIVING RECORDS FOR ITEM# GNLR BATCH# 090AF1056, ITEM# BUBBLEGUM BATCH# 200905660 & ITEM# TB PINK BATCH# 6505940 HAVE ALSO BEEN ATTACHED TO THIS CASE. FOR EACH RAW MATERIAL, RECEIVING INSPECTION IS ACCEPTED BASED OFF SUPPLIER¿S CERTIFICATION AS PER 0290-IP-7.5-80-11 (CURRENT DOCUMENT WHICH SUPERSEDED 0290-IP-RI-COLORS & RESINS WHICH WAS CURRENT AT THE TIME OF RECEIPT OF EACH RESIN/COLORANT). EACH MATERIAL CERTIFICATION WAS VERIFIED TO MEET SPECIFICATION AS PER 0290-SPEC-028: MATERIAL SPECIFICATION FOR CHEWIE ALIGNER SEATERS. (NWV) RETAIN (B)(6) 2023: RETAINS WERE NOT AVAILABLE FOR REVIEW AS PER 0290-WI-8.2-07 WHICH STATES RETENTION SAMPLES MUST BE MAINTAINED FOR A MINIMUM OF SIX MONTHS (PRODUCED 07-2022). (NWV) FAILURE MODE: ALLERGIC REACTION ROOT CAUSE: NO DEFECT PROVEN CONCLUSION CODE: NO FAILURE FOUND.