Model Number PCDR1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hernia (2240); Discomfort (2330)
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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.
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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) 2018 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2018 during which the surgeon noted the mesh had migrated to the right, thereby exposing the lateral left for recurrent hernia.It was reported that the patient experienced mesh migration, abdominal pain, and discomfort.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2021.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: 5/5/2021.
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Search Alerts/Recalls
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