D
Patient 1
SPONTANEOUS REPORT, FROM (B)(6). (B)(4). INITIAL INFORMATION WAS RECEIVED FROM THE DENTIST BY THE DISTRIBUTOR (B)(4) AND FORWARDED TO THE MANUFACTURER SOFIC ON 17-DEC-2018 AND FOLLOW-UP 1 INFORMATION RECEIVED ON 21-DEC-2018 FROM THE DISTRIBUTOR (B)(4) BY EMAIL. THE DENTIST REPORTED THAT THE SUSPECT DEVICE AIGUILLES 30G COURT 0.3X21MM (BATCH # F06953AA, EXPIRATION DATE : UNK) WAS USED ON A FEMALE PATIENT WITH AN UNSPECIFIED AGE AND MEDICAL HISTORY FOR A TRONCULAR LOCAL ANAESTHESIA (TO THE SPIX SPINE) ON CHEEK ON (B)(6) 2018. SHE WAS NOT FEELING ANXIOUS DURING THE DENTAL CARE. ON (B)(6) 2018, THE DENTIST PERFORMED THE FIRST INJECTION WITH SUCCESS AND DURING THE SECOND INJECTION, THE NEEDLE BROKEN AT THE BASE AND REMAINED STUCK INSIDE THE TISSUES OF THE PATIENT'S CHEEK. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO STOMATOLOGY UNIT TO REMOVE THE NEEDLE, THE PROCEDURE WAS UNSUCCESSFUL. SHE WAS OPERATED UNDER GENERAL ANESTHESIA TWICE (AT (B)(6) HOSPITAL IN THE MAXILLOFACIAL SURGERY DEPARTMENT AND AT (B)(6) HOSPITAL). A CT-SCAN WAS PERFORMED, NO VALUE AVAILABLE. AT THE TIME FOR THIS REPORT, THE PATIENT'S OUTCOME WAS NOT RECOVERED DUE TO THE NEEDLE WAS STILL STUCK. NO FORCE WAS APPLIED TO THE NEEDLE DURING THE INJECTION. THE CUSTOMER TOLD US NOT TO HAVE A PHOTO. SHE DID NOT KEEP THE OTHER BROKEN END, BUT SHE KEPT THE BOX WITH THE OTHER NEEDLES, WHICH SHE PREFERRED TO KEEP THE TIME THAT HER INSURANCE COMES BACK TO HER. NO SAMPLE WAS AVAILABLE YET. CAUSALITY ASSESSMENT ON 26-DEC-2018 ON INITIAL INFORMATION RECEIVED ON 17-DEC-2018 AND ADDITIONAL INFORMATION RECEIVED ON 21-DEC-2018: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) AND HOSPITALISATION). EXPECTEDNESS: FOREIGN BODY IN GASTROINTESTINAL TRACT: UNEXPECTED (B)(6)/US. NEEDLE ISSUE: UNEXPECTED (B)(6)/US. CAUSALITY: LATENCY - COMPATIBLE. RECOGNIZED ASSOCIATION - NO. ANALYSIS - THE POSSIBLE CAUSES FOR THE REPORTED EVENT MAY BE THE BENDING OF THE NEEDLE BEFORE USE, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR A QUALITY ISSUE OF THE PRODUCT. AT THE TIME OF THE REPORT, THE SAMPLE OF THE BROKEN WAS NOT AVAILABLE. THEREFORE THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS WAS CONSIDERED AS NOT ASSESSABLE. DECHALLENGE - NA. RECHALLENGE - NA. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE.