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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Ulcer (2274)
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Event Date 03/01/2020 |
Event Type
Injury
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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.(b)(4).Attempts are being made to obtain 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.Can you please clarify how many patients have experienced this reported issue? a separate product complaint would be required for each.Were any cases previously reported to us? if yes, please provide the product complaint number assigned.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? other relevant patient history/concomitant medications? what were current symptoms following the index surgical procedure? onset date? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any intra-operative complications? please clarify what is meant by "deep ulceration" in relation to the suture.When was the ulceration first noted by a physician? ulceration site/location, symptoms and diagnostic confirmation? date and surgical findings from re-operation? can you describe the appearance of the stratafix suture and/or ¿foreign material¿ during surgical intervention? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? product code and lot number? will any product be returned for analysis? are photos available for evaluation? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported that a patient underwent an abdominoplasty procedure on an unknown date in 2020 and suture was used.The patient experienced deep ulcerations and foreign material resembling suture having to be removed requiring further intervention and hospital episodes.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Date sent to fda: 05/04/2021.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: surgeon has noticed wound breakdown in his patient 3 months after abdominoplasty.Patient sent him a photo with stratafix sticking out of the wound.He also noted that he has had leaks with staples (enseal and medtronic).He also noted that he has the same problems with the stratafix sticking out of the wound when using v-loc 90.Surgeon is still using stratafix as he likes the efficiency of it.Can you please clarify how many patients have experienced this reported issue? a separate product complaint would be required for each.No specific number provided related to suture.Surgeon said he has had 8 patients with leaks (enseal and medtronic), plus other patients over an 8 month period, he has done 8 lists in 8 months.The patient demographic info: age, gender, weight, bmi at the time of index procedure one patient had a bmi of 28.On what tissue was the suture used? subcutaneously and in the fat layer.Can you describe the appearance of the stratafix suture and/or ¿foreign material¿ during surgical intervention? stratafix was sticking out to the wound.Wound had broken down.Are photos available for evaluation? photos to follow.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m (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.
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Search Alerts/Recalls
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