[130466044]
Spontaneous report, from the united states. (b)(4). Initial information was received on 1(b)(4) 2018 by dealer and forwarded to septodont on 19-nov-2018. On (b)(6) 2018, the dentist reported that suspect device patterson 30g short needle (batch # and expiration date not yet available) on a patient (unspecified age, gender, medical history). The dentist performed an ia injection on the patient's right side. When the dentist pulled the needle from the patient's mouth, the suspect needle was reported "looked very flimsy/fragile". The dentist then replaced with a brand new suspect device. The dentist then injected the patient's left side with the brand new needle. The needle went in once, injected a small amount, withdrawn, and re-inserted at a "slight different angle". When the dentist pulled the needle out the second time, the dentist noted that the needle had stayed in the patient's cheek ("broke off in my patient's face"). On (b)(6) 2018, the needle was extracted under general anesthesia by an oral surgeon. Samples are expected to be returned for evaluation. Additional information is pending via dealer's legal department. The company decided to add needle issue as coding. Causality assessment on 30-nov-2018 on initial information received (b)(4) 2018: seriousness: serious (required intervention to prevent permanent impairment/damage (devices)). Listedness/ expectedness: foreign body in gastrointestinal tract: unlisted eu, unexpected us/(b)(4). Needle issue: unlisted eu, unexpected us/c(b)(4). Causality: latency - compatible. Recognized association - no. Analysis - in this case, the cannula of the needle has detached or broke during injection in cheek. The dentist identified a potential defect with another needle from the same batch (needle very flimsy) and no other information was provided if the needle was bent before use or if excessive pressure, movement of the needle or a sudden movement of the patient occurred during injection. Quality investigation is ongoing; at the time of this report, information are not sufficient to allow any causality assessment. Pending the results of investigation of the defect, the case report was considered as not assessable. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5