ETHICON INC. GYNECARE TVT EXACT CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number TVTRL |
Device Problem
Break (1069)
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Patient Problem
Nonresorbable materials, unretrieved in body (2276)
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Event Date 10/18/2013 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2013.During the procedure, while the surgeon was inserting the trocar sheath, approximately 3mm of the tip of the trocar sheath broke off in the patient.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This medwatch report is in response to receipt of maude event report (b)(4).
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Search Alerts/Recalls
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