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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); Foreign Body Reaction (1868); Inflammation (1932)
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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.Mwr (b)(4) submitted for adverse event which occurred on (b)(6) 2013.Mwr (b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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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 partial removal surgery on (b)(6) 2013.It was reported that the patient underwent revision surgery on (b)(6) 2020.It was reported that the patient experienced severe and chronic pain, inflammation, lysis of adhesions between small bowel and foreign body giant cell reaction.No additional information is provided.
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Search Alerts/Recalls
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