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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Nausea (1970); Pain (1994); Hernia (2240); 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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(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.(b)(4) submitted for adverse event which occurred on (b)(6) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted the mesh had torn down the middle.It was reported that the patient underwent surgery on (b)(6) 2019 during which the surgeon noted infected hematoma which was incised, drained and irrigated.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite.Other procedure was captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/28/2021 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: 7/25/2023.H6: appropriate term / code not available (e2402) utilized to capture bulging of his abdominal wall, and drainage from wound.It was reported that the patient experienced hernia recurrence, bulging of his abdominal wall, and drainage from wound.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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