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Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); 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.(b)(4) submitted for the adverse event which occurred on (b)(6) 2011.(b)(4) submitted for the adverse event which occurred on (b)(6) 2012.
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2011 during which the surgeon noted ¿underlying abscess cavity and infected mesh.¿ it was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted ¿persistent inflamed mass within the abdominal wall.¿ it was reported that the patient experienced infections, mesh contraction, severe pain, recurrence, nausea, chills, inflammation, loss of appetite, stress and anxiety.The patient had a previous mesh implanted on (b)(6) 2009 which is 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: 3/15/2021.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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Search Alerts/Recalls
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