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Catalog Number TVTRL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 08/25/2023 |
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? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Please describe the drug therapy provided for the yeast vaginitis including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to these events (yeast vaginitis, voiding dysfunction, levator spasm)? what is the patient's current status? surgeon¿s name? facility 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 an unknown procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, mild voiding dysfunction, mild yeast vaginitis and mild levator spasm were noted.Unspecified drug therapy was provided for the yeast vaginitis.The mild voiding dysfunction was reported as possibly related to the study device and study procedure.The yeast vaginitis was reported as not related to the study device, but possibly related to the study procedure.The levator spasm was reported as unlikely related to the study device and possibly related to the study procedure.These events have not been recovered/resolved.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 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, 103.4kg, 33.7.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 ¿ cystoscopy, rectocele repair and perineorrhaphy.Other relevant patient history/concomitant medications? see edc.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? yes ¿ cefazolin pre-op were cultures performed? if so, please provide the results.No culture.Please describe the drug therapy provided for the yeast vaginitis including medication name and results.Diflucan ¿ no results noted in chart.What is the physician¿s opinion as to the etiology of or contributing factors to these events (yeast vaginitis, voiding dysfunction, levator spasm)? puborectalis and coccygeus tenderness ¿ levator spasm and voiding dysfunction - what is the patient's current status? ongoing.Surgeon¿s name? (b)(6).Facility name? (b)(6).Product code and lot number? tvtrl - 3943926.
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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.
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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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