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Catalog Number 0112760 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 02/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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As reported, post implant of the perfix plug, the patient experienced increasing pain in left groin and scrotum.The information provide is limited, and based on the information received to date, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in aug, 2018.Not returned - remains implanted.
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Event Description
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As reported, during the left inguinal hernia repair procedure, the patient was implanted with a bard/davol perfix plug.As reported, post implant of the mesh on (b)(6) 2020, the patient experienced an increase in pain to left groin and scrotum, along with mobility issues.
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Search Alerts/Recalls
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