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Model Number PCDN1 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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 adverse event which occurred on (b)(6) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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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 implanted.It was reported that the patient underwent midline hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2018.It was reported that the patient underwent revision surgery on (b)(6) 2019.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, unstable mesh and adhesions.No additional information was provided.
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Search Alerts/Recalls
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