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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); 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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(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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2010.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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Event Description
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It was reported by an attorney that the patient underwent a ventral hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent partial revision surgery on (b)(6) 2010.It was reported that the patient underwent another mesh removal surgery on (b)(6) 2018.It was reported that the patient experienced pain, nausea, diarrhea, chills, inflammation, fluid retention and kidney problems.No additional information was provided.
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Search Alerts/Recalls
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