[168781243]
Spontaneous report, from the united states. Local reference #: (b)(4). Quality complaint reference #: (b)(4). Dealer complaint reference #: (b)(4). Initial information received on 29-oct-2019 from a dentist via dealer sales representative. Follow-up #1 information received on 30-oct-2019 from a dentist via dealer sales representative. Follow-up #2 information received on 06-nov-2019 from a dentist via dealer. Initial and follow-up information are integrated in below case narrative. On 29-oct-2019, the dentist reported that a a (b)(6) male patient (body weight: (b)(6)), with a medical history of tooth 15 reucrrent caries and acid reflux, had been treated with suspect device darby private label needle 30g short (batch # f08110aa, expiration date: 2023-12) on (b)(6) 2019. The patient was reported not anxious prior to dental treatment. The suspect device was used for an infiltration injection for dental local anesthesia with 2 cartridges of concomitant medication. Lidocaine 2% hcl with epinephrine 1:100,000 (batch number and expiration date: not reported) in the upper left for tooth #15 (corrected form tooth #16 reported previously on 30-oct-2019) via buccal route. The needle was reported not pre-bent. The injection site was reportedly healthy. Topical anesthetic (active ingredients not specified) was applied at the injection site prior to injection. Indication of the dental treatment with the suspect device was for injection of dental local anesthesia by infiltration via buccal route for removal of existing amalgam filling and to evacuate decay with recurrent dental caries in tooth #15. On(b)(6) 2019, at the time of use of suspect device, the patient was complaining of pain in tooth #15. On (b)(6) 2019, when the dentist finished the injection, when the syringe was pulled back, the dentist noticed the suspect device had broken from the hub ("needle not attached to drum"). The needle was found embedded in the patient's cheek muscle and it was not possible to retrieve it. The patient was taken to the emergency room and were not able to be help. On an unspecified date, the patient underwent panoramic dental x-ray (results: not provided), maxillofacial ct scan (results: needle lodged in lateral pterygoid muscle) and was scheduled to have oral surgeon to remove the needle but he reportedly did not show up. On (b)(6) 2019, the patient went to see oral surgeon (outcome: not provided) and was scheduled for a follow-up appointment in (b)(6) 2020. The intended dental treatment reportedly was not completed as intended due to the incident. The patient received following post-operative medications: amoxicillin 500 gm, ibuprofen 600 mg. At the time of the report, the patient's outcome was unknown. Additional information expected. Follow-up #1 information on (b)(6) 2019: dentist information, patient status update, injection site information, injection technique used and condition of the needle prior to injection. Follow-up #2 information on (b)(6) 2019: updated: patient demographics, patient status update, injection site information, injection technique used, concomitant medications, patient's medical history, intention for dental treatment. Corrected tooth involved in dental treatment from #16 to #15. Added new reaction term: toothache; removed reaction term: no adverse event. Added tests performed and upcoming scheduled appointment between patient and oral surgeon. Causality assessment on (b)(6) 2019 on initial information received on 29-oct-2019 and additional information received on 30- oct-2019. Re-evaluated on 27-nov-2019 on additional information on 06-nov-2019: seriousness: serious (required intervention to prevent permanent impairment/damage (devices), other medically important condition) expectedness: foreign body in gastrointestinal tract: unexpected us. Needle issue: unexpected us. Toothache: unexpected us. Causality: latency: compatible. Recognized association: no. Analysis: the device broke from the hub and the needle was found embedded in the patient's cheek muscle and not possible to retrieve. The possible causes for the reported event may be excessive pressure or movement of the needle during injection, a sudden movement of the patient during injection and/ or quality issue. The patient experienced toothache. This may be linked to his recurrent history of caries on tooth #15 (the treated tooth as well) or due to the dental procedure. At the time of the report, there was no information to identify a misuse or inappropriate usage during the local injection. No other claims have been registered on the batch. Awaiting quality investigation results, no capa is deemed necessary. The causal relationship between the device and the events was considered as not assessable. Dechallenge - na. Rechallenge - na. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5