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Model Number PML |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Swelling/ Edema (4577); 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.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.
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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and two mesh products were implanted.It was reported that the patient underwent revision surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2014.It was reported that the patient experienced chronic pain, inflammation, swelling, bowel obstruction and gastrointestinal malfunction.Other procedures are captured under separate files.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 6/13/2022.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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