Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Pain (1994); Hernia (2240); Numbness (2415)
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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) 2019 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020.It was reported that the patient experienced severe pain, weakness and numbness.No additional information was provided.
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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.
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Manufacturer Narrative
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Date sent to the fda: 4/22/2022.
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Search Alerts/Recalls
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