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Catalog Number TVTRL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Unspecified Kidney or Urinary Problem (4503)
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Event Date 02/05/2024 |
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.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure: female, 64.5kg, 28.70.Date and name of index surgical procedure? sling operation for stress incontinence.The diagnosis and indication for the index surgical procedure? stress incontinence.Were any concomitant procedures performed? yes.What symptoms did the patient experience following the index surgical procedure? onset date? (b)(6) 2024 ¿ urgency urinary incontinence, urgency.Other relevant patient history/concomitant medications? no.Please describe any medical intervention performed including medication name and results.Oxybutynin, pelvic floor physical therapy- ongoing.What is the physician¿s opinion as to the etiology of or contributing factors to this event? overactive bladder.What is the patient's current status? ongoing.Product code and lot number? tvtrl - 3943851.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) 2023 and mesh was implanted.On (b)(6) 2024, mild overactive bladder was noted which included urgency urinary incontinence.The patient was provided with oxybutynin and pelvic floor physical therapy that is ongoing.This event was reported as possibly related to the study device and 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
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Search Alerts/Recalls
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