Product complaint # (b)(4).Component code: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental will be sent.Additional information was requested, and the following was obtained via: please provide the lot number: sbbact.Photo analysis: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a suture product code (b)(4).The suture is shown in two pieces.Unfortunately, the photo does not provide enough evidence to determine the root cause.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Events reported via: 2210968-2023-00036.
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It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, it was reported that the suture broke when sewing in an unknown surgery.Changed another one to continue the surgery, the same problem happened again.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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