ETHICON INC. STFX SPI PDS+ UNI VIO 9IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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Model Number SXPP1B433 |
Device Problems
Break (1069); Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and a barbed suture was used.During the procedure, the suture kept breaking apart and the barbs would not catch.It was unknown how the procedure was completed.There were no adverse consequences for the patient reported.No additional was provided.
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Manufacturer Narrative
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(b)(4).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.(b)(4).Device not returned.Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: please provide the lot number: shbhkq.Device return status: returning remaining stratafix in box.Note: related events reported 2210968-2022-10516, 2210968-2022-10517, 2210968-2022-10518, 2210968-2022-10519 and 2210968-2022-10520.
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Manufacturer Narrative
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Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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Search Alerts/Recalls
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