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Model Number PCDW1 |
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); Weight Changes (2607); Decreased Appetite (4569)
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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.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2012.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.
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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) 2011 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted extensive adhesions.It was reported that the patient underwent removal surgery on (b)(6) 2014 and mesh was implanted during which the surgeon noted extensive adhesions and a hernia recurrence.It was reported that the patient underwent a surgical procedure on (b)(6) 2014 during which a wound vac was placed.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
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Search Alerts/Recalls
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