Model Number PCDT1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994)
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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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
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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) 2008 and mesh was implanted.It was reported that the patient underwent partial removal surgery on (b)(6) 2013 during which the surgeon noted surgeons found small bowel perforation adhered to the abdominal wall, abdominal wall abscess and necrotizing soft tissue infection, significant and concrete adhesions to the bowel surrounding the bowel perforation.It was reported that the patient underwent partial removal surgery on (b)(6) 2017 during which the surgeon noted necrotizing infection of the anterior abdominal wall involving skin and subcutaneous tissue muscle fascia and abdominal wall all secondary to an enterocutaneous fistula with the small bowel.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 6/29/2022.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.
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Manufacturer Narrative
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Date sent to the fda: 7/25/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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