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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Fistula (1862); Inflammation (1932); Pain (1994); Discomfort (2330); 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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Appropriate term / code not available (e2402) utilized to capture infection (e19) 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 hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, adhesions to bowel, bowel resection, abscess, infection and fistula.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 2/15/2022.Additional information: a2, d3.
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Search Alerts/Recalls
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