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Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240); Not Applicable (3189)
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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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017.It was reported that the patient experienced severe and chronic pain, inflammation, recurrence, emotional distress and anguish.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2021.Additional information: a1, a2, b7, d3.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia and adhesions following surgery.
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Search Alerts/Recalls
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