Catalog Number SPMLI |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Prolapse (2475); Cramp(s) /Muscle Spasm(s) (4521); 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) 2007 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2019.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 05/30/2021.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: 9/14/2021.Additional b5 narrative: it was reported that the patient experienced urinary incontinence, pain and cramps following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2019 due to bladder prolapse, vaginal mesh erosion and cystocele.
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Search Alerts/Recalls
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