CALIBRA CERAM MED REFILL
Received Sep 25, 2024
Report 2515379-2024-00047 · MDR key 20299883
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT CALIBRA CERAM MED REFILL POSSIBLY CAUSED A PATIENT TO HAVE A REACTION. THE SYMPTOMS OCCURRED AFTER TREATMENT WERE REDNESS, SWELLING OF THE PAPILLAE AND HEAVY BLEEDING. REPORTEDLY NOT INJURY OCCURRED.
Additional Manufacturer Narrative
INVESTIGATION: PRODUCT WILL NOT BE RECEIVED. LOT NUMBER UNKNOWN, SO DHR CANNOT BE COMPLETED. UNSUCCESSFUL ATTEMPTS TO RETRIEVE SUSPECT PRODUCT FOR INVESTIGATION/EVALUATION HAVE BEEN MADE AND DOCUMENTED. COMPLAINT WILL BE REOPENED, IF SUSPECT PRODUCT OR INVESTIGATION RESULT ARRIVES, PER 8000-SOP-038.