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Model Number PHSM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015.It was reported that the patient experienced severe and chronic pain, inflammation and bulging and knotted muscles.
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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.
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Manufacturer Narrative
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Date sent to the fda: 08/10/2022.Additional b5 narrative: it was reported that the patient experienced hernia recurrence, seroma, swelling and discomfort following surgery.
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Search Alerts/Recalls
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