D
Patient 1
SPONTANEOUS REPORT, FROM (B)(6). (B)(4). INITIAL INFORMATION RECEIVED ON 01-APR-2019 FROM THE DENTIST DURING QUALITY INVESTIGATION. THE DENTIST REPORTED THAT SHE USED DENTAL SHORT NEEDLE SEPTOJECT (BATCH F06214AB) ON SEVERAL PATIENTS (UNSPECIFIED GENDER) WITH NO SPECIFIED MEDICAL HISTORY. ON UNSPECIFIED DATE, BEFORE PERFORMING INTRASEPTAL AND INTRALIGAMENTARY INJECTIONS ON PATIENTS, THE DENTIST BENDED THE NEEDLES. DURING INJECTIONS, THE NEEDLES BROKEN IN PATIENTS' MOUTH. THE FRAGMENTS COULD BE RECOVERED WITHOUT ANY ADVERSE EFFECT ON THE PATIENT BY THE PRACTITIONER. THE PATIENTS RECOVERED. THE COMPANY CODED "WRONG TECHNIQUE IN DEVICE USAGE PROCESS" SINCE THE DENTIST DID NOT RESPECT THE INSTRUCTIONS OF USE MENTIONED IN THE IFU. ADDITIONAL INFORMATION WILL FOLLOW. CAUSALITY ASSESSMENT ON 05-APRIL-2019 ON INITIAL INFORMATION RECEIVED ON 01-APR-2019: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)). EXPECTEDNESS: FOREIGN BODY IN MOUTH: UNEXPECTED (B)(6)/US; NEEDLE ISSUE: UNEXPECTED (B)(6)/US; WRONG TECHNIQUE IN DEVICE USAGE PROCESS: UNEXPECTED (B)(6)/US; NO ADVERSE REACTION: EXPECTED (B)(6)/US. CAUSALITY: LATENCY - COMPATIBLE; RECOGNIZED ASSOCIATION -NO; ANALYSIS -THE REPORTED INCIDENT OF DEVICE BREAKAGE IN PATIENT MOUTH SEEMS TO BE MORE LIKELY DUE TO THE INAPPROPRIATE DEVICE USE SINCE IT WAS BENDED PRIOR TO THE USE. THEREFORE THE CAUSALITY IS ASSESSED AS UNLIKELY. DECHALLENGE -NA. RECHALLENGE - NA. CONCLUDED CAUSALITY WHO: UNLIKELY.