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Model Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Perforation (2001); Hernia (2240)
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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) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted infected mesh and severely adherent small bowel loops to the infected mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 12/15/2020.Additional information: a1, a2, b7.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia, bowel perforation and fistula.
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Search Alerts/Recalls
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