Catalog Number SPML1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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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.Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2017.Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2017.Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2020.
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Event Description
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It was reported by an attorney that the patient underwent bilateral hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent revision surgeries on (b)(6) 2017, (b)(6) 2017 and (b)(6) 2020.It was reported that the patient experienced chronic pain, inflammation, swelling, bowel obstruction and gastrointestinal malfunction.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/10/2021.
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Manufacturer Narrative
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Date sent to the fda: 11/16/2021.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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