Model Number PCDR1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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) 2019 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, open draining wound, mesh sticking out of stomach, fatigue, nausea and vomiting.No additional information was provided.
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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.
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Manufacturer Narrative
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Date sent to the fda: 6/27/2022 additional information: d4, h4 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: 5/24/2022.Additional b5 narrative: it was reported that following the procedure the patient experienced infected abdominal wound and debridement of small amount of avascular tissue from the wound.
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Search Alerts/Recalls
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