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Catalog Number TVTRL |
Device Problem
Migration (4003)
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Patient Problems
Abdominal Pain (1685); Erosion (1750); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Urinary Retention (2119); Prolapse (2475); Unspecified Kidney or Urinary Problem (4503)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 4/25/2024 to date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure in 2014 and an unk mesh was implanted.It was reported that the patient experienced mesh failing, the bladder is falling out and the mesh is no longer holding it in place and it was in the vaginal cavity.It was also reported that the patient experienced bladder prolapse, abdominal pain and pain in her back around where her kidneys, incomplete emptying of the bladder, incontinence, and blood pressure running high around 142/90.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2024 additional information: d4, h4 a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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, or its employees that the report constitutes an admission that the product, ethicon, 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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Search Alerts/Recalls
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