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Model Number PML |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Seroma (2069); 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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Date sent to fda: 8/9/2021.(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) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
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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) 2014 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015, (b)(6) 2015, (b)(6) 2015 and (b)(6) 2017.It was reported that the patient experienced infection, seroma, mesh adhesion, abdominal complications and chronic pain.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/23/2021.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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