Product complaint (b)(4).No device problem found.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information was requested, and the following was obtained via: 6 eaches used monday.1 used today (separate complaint).The remaining of the lot was pulled off the shelf (1 box + 6 eaches).Analysis: the product was returned for evaluation.Visual inspection was conducted on the returned devices.Visual analysis of the returned sample determined that it was received twelve unopened samples that pertain to the product code sxpp1a400.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or fixation tab failure were observed during evaluation, and the tab was intact and attached to the suture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name irgacare.Active ingredient(s) triclosan.Dosage form suture/solid/parenteral.Strength 2360 g/m.Events reported via: 2210968-2022-10704, 2210968-2022-10705, 2210968-2022-10752, 2210968-2022-10796, 2210968-2022-10793.
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