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Model Number PVPS |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Cramp(s) (2193); Hernia (2240)
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Event Type
Injury
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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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Event Description
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It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2015 and mesh were implanted.It was reported that the patient had a mesh removal surgery on (b)(6) 2016 at (b)(6) hospital in (b)(6).It was reported that the patient continues to experience pain, nausea, diarrhea, chills, inflammation, loss of appetite and weight loss.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 6/27/2019.Corrected narrative: it was reported that the patient had a mesh removal surgery on (b)(6) 2016.
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Manufacturer Narrative
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Date sent to fda: 09/17/2020.Additional narrative: it was reported that the patient experienced hernia recurrence, cramping, constipation and scar tissue following surgery.
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Search Alerts/Recalls
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