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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Constipation (3274); Decreased Appetite (4569); 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.
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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) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted there were adhesions of incarcerated omentum to the mesh.There was also a recurrent hernia.The mesh was removed and it was necessary to remove portions of the omentum as well as the hernia sac.A bilateral myofascial release was performed.It was reported that the patient experienced severe pain, nausea, constipation, bulging, inflammation and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/18/2021.
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Search Alerts/Recalls
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