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Model Number SXPP1A404 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Not Applicable (3189)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date sent to the fda: 10/29/2020.(b)(4).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.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue was each stratafix suture (sxpp1a404, sxpp1b411 and sxmp1b111) used? please specify.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? for stratafix spiral sutures: was fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? for stratafix symmetric: was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? did the operating surgeon observe any suture deficiency or anomaly before, during or after suture placement? what tissue dehisced? please specify.Was there any precipitating stress factor for the wound dehiscence? what date did the patient present with dehiscence (# of post-op days)? what was the appearance of each stratafix suture (symmetric pds plus, spiral pds plus and spiral monocryl plus) during re-suturing procedure? did all stratafix sutures break, if so, where (termination, middle, end)? other relevant patient comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? product lot numbers for each stratafix (sxpp1a404, sxpp1b411 and sxmp1b111)? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2020-08474 and 2210968-2020-08475.
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Event Description
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It was reported that a patient underwent an unknown procedure in 2020 and the barbed suture was used.Post-operative, the patient experienced wound dehiscence and was re-sutured.Additional information has been requested.
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Manufacturer Narrative
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Date sent to the fda: 12/03/2020.H-6 component code: g07002- device not returned.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.Date sent to the fda: 12/03/2020.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.
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Search Alerts/Recalls
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