Catalog Number TVTOML |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Injury (2348); Not Applicable (3189)
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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 product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and mesh was implanted.It was reported that the patient has underwent revision surgery on (b)(6) 2019.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 12/29/2020.Additional b5 narrative: it was reported that the patient underwent excision of mesh on (b)(6) 2019 due to mesh exposure.
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Manufacturer Narrative
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Date sent to the fda: 1/14/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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