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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994); 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 the fda: 08/20/2021.(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 the adverse event which occurred on (b)(6) 2015.(b)(4) submitted for the adverse event which occurred on (b)(6) 2018.(b)(4) submitted for the 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 hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent hernia repair surgery with removal of meshomas on (b)(6) 2018.It was reported that the patient underwent removal surgery, lysis of adhesions, lysis of adhesions of the mesh to cord structures, left orchiectomy and removal of spermatic cord section on (b)(6) 2020.It was reported that the patient experienced severe pain, nerve entrapment and nerve damage which resulted in orchiectomy and neurectomy.Other procedure is captured under separate file.No additional information was provided.
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Search Alerts/Recalls
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