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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994)
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Event Type
Injury
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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) 2001 and mesh was implanted.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2017.It was reported that the patient experienced severe pain, dense adhesions, stress and anxiety.The other procedure is captured in a separate file.
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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-31102022-0001288748 submitted for adverse event which occurred on (b)(6) 2016.Mwr-31102022-0001288747 submitted for adverse event which occurred on (b)(6) 2017.
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Search Alerts/Recalls
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