Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Decreased Appetite (4569)
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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) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2009 during which the surgeon noted extensive omental adhesions to the mesh.The extensive adhesions to the mesh were lysed and the mesh was removed.It was reported that the patient experienced severe pain, nausea, chills, constipation, cramps and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 4/13/2022.Additional b5 narrative: it was reported that patient experienced recurrent ventral hernia following surgery.
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Manufacturer Narrative
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Date sent to the fda: 08/21/2022.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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