ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994)
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Event Date 02/19/2024 |
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.The following information was requested, but unavailable: please provide the patient's demographic information including age, 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 provide the mesh exposure symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.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? 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.Related events captured via 2210968-2024-04589.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2022 and mesh was implanted.On (b)(6) 2023, control was needed due to pain in the vein and fossa.Agreed on stretching exercises.On (b)(6) 2024, the patient needed control of pain over the symphysis and morphine was provided via own doctor.At this time, erosion was seen below midureteral - left legs of the sling mesh feel.Additional information was requested, but unavailable.
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