(b)(4). A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure on what tissue what the suture used? What was the tissue condition, i. E. Normal or thin, calcified, fragile, diseased? What instruments were used to grasp the needle? Where was the needle grasped during use? Was the entire device removed from the patient on (b)(6) 2020? Does the piece/device remain retained in the patient? S tissue? If the pieces were retained, where is the device located/in what structure? Other relevant patient history/concomitant medications. Will the actual device be returned for evaluation? Will representative samples from the same lot be returned for evaluation? What is physician? S opinion as to the etiology of or contributing factors to this event?
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient underwent a c-section procedure on (b)(6) 2020 and the suture was used for skin closure. While at the right angle of a surgical wound, there was a rupture/breakage of the needle in the proximal third. It was also reported that more than half the needle was retain in the patient. Exploration of the surgical wound was performed with soft tissue ultrasound and rx intraoperative abdomen without finding the needle. It was reported that the patient had to be re-operated on (b)(6) 2020 in order to extract the needle which was found in the subcutaneous tissue. The patient had to stay one more day in the hospital. The patient was well and released on (b)(6) 2020. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5