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Catalog Number PMLK |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Pain (1994); Scarring (2061); Discomfort (2330); Hypoesthesia (2352); No Code Available (3191)
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Event Type
Injury
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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 info derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent a recurrent left inguinal herniorrhaphy on (b)(6) 2015 and mesh was implanted.The mesh was explanted on (b)(6) 2017 by dr (b)(6) at the (b)(6) clinic, and mesh was implanted.
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Manufacturer Narrative
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Manufacturer Narrative
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It was reported that following insertion the patient experienced post hernia groin pain, scarring, inflammation, numbness, discomfort, and associated constipation.
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Manufacturer Narrative
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Date sent to fda: 6/25/2019.
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Search Alerts/Recalls
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