ETHICON INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Urinary Retention (2119)
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Event Date 02/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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.Please provide the patient's demographic information including gender, weight, bmi at the time of index procedure.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? please describe any medical intervention performed including medication name and results.Please describe any surgical intervention performed including procedure name and results.Were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product code and lot number? 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.H6 component code: g07002 ¿ device not returned.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2024 and mesh was implanted.On (b)(6) 2024, it was noted that the sling was too tight (moderate).The patient underwent "solution of tvt sling" and the event was recovered/resolved as of 09 feb 2024.This was reported as having a causal relationship with the study device and study procedure.On (b)(6) 2024, mild cystitis was noted.Unspecified drug therapy was provided and the event was recovered/resolved as of (b)(6) 2024.This was reported as unlikely related to the study device and probably related to the study procedure.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).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.Additional information: h6.Additional information received: adverse event term: tvt sling to tight : residual urine because the tvt sling to tight adverse event term: cystitis.Start date:(b)(6) 2024.End date: (b)(6) 2024.Severity: mild.Relationship to study device: unlikely.Relationship to primary study procedure: possible.Drug therapy: yes.Outcome: recovered/resolved without sequelae.
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Search Alerts/Recalls
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