ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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Model Number SXPP1B404 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Necrosis (1971)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a total knee procedure on an unknown date in 2022 and barbed suture was used.Post-op, the patient had necrotic wound.Current patient status unknown.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4).Additional information has been requested and the following was received.If further details are received at a later date a supplemental medwatch will be sent.No additional information is available at this time.In what area or tissue was the severe necrotic tissue? patient experienced a mild case of necrosis, no additional information is available at this time.Is photo available of patient's necrosis? no.What was the procedure date? not provided.Were any cultures taken? results? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown name of surgeon? dr.(b)(6) current patient status.Unknown.In the manner the stratafix was used on each patient, is it believed to have contributed to necrosis? our belief is that the way the stratafix was ¿double backed¿ could have caused strangulation of the tissue which resulted in the necrosis.In the manner the stratafix was used on each patient, is it believed to have contributed to some other issue, please specify? (no response).No product is available for return.Note: events reported on: mw# 2210968-2023-00431, mw# 2210968-2023-00432, mw# 2210968-2023-00434.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ¿g/m.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.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information; h6.Health effect - impact code.Note: events reported on: mw# 2210968-2023-00431, mw# 2210968-2023-00433, mw# 2210968-2023-00434, mw# 2210968-2023-00453.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.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.
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