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Catalog Number PFRT02 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2009 and mesh was implanted.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 6/24/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 4/1/2022.H6: appropriate term / code not available (e2402) utilized to capture mesh migration additional information: a1, a2, b7, d6b additional b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2018 due to pain, mesh migration, pudendal nerve damage and excessive scarring.
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Search Alerts/Recalls
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