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Model Number PCDM1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Obstruction/Occlusion (2422)
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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.
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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.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, excision of lesion of spermatic cord/mesh partially obstructed the spermatic cord.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/30/2021.
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Search Alerts/Recalls
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