Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted he lysed extensive adhesions to the mesh.The mesh eventuating into the hernia defect was removed.It was reported that the patient experienced severe pain, nausea, diarrhea, inflammation, and bulging.No additional information was provided.
|
|
Manufacturer Narrative
|
(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.
|
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted he lysed extensive adhesions to the mesh.The mesh eventuating into the hernia defect was removed.It was reported that the patient experienced severe pain, nausea, diarrhea, inflammation, and bulging.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to the fda: 12/1/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Search Alerts/Recalls
|