ETHICON INC. TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Therapeutic Response, Decreased (2271); Not Applicable (3189)
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Event Date 07/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications product code and lot number if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient current status?.
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Event Description
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It was reported that the patient underwent surgical procedure on an unknown date and mesh was implanted.Following the procedure, the patient experienced discomfort at the insertion site, failed mesh, increasing and florid stress urinary incontinence, pain increasing at the insertion site.The patient also experienced tender vaginal tissue over the mesh, failure of the mesh, pain during intercourse, tape palpation over the left groin and left groin pain.The mesh was removed on (b)(6) 2018.Additional information has been requested.
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Search Alerts/Recalls
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