Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Pain (1994); Chills (2191); Hernia (2240); Discomfort (2330); 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.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(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 hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2018.It was reported that the patient underwent drainage of serous fluid on (b)(6) 2018.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss (50 pounds).No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 06/11/2021.Additional b5 narrative: it was reported that the patient experienced discomfort, adhesions and hernia recurrence following surgery.
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Manufacturer Narrative
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Date sent to the fda: 7/12/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 12/13/2021.Additional b5 narrative: it was reported that the patient underwent removal surgery on (b)(6) 2018.
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Search Alerts/Recalls
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