|
Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569)
|
Event Type
Injury
|
Manufacturer Narrative
|
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) 2017 and mesh was implanted.It was reported that the patient underwent recurrent hernia on (b)(6) 2020 during which the surgeon noted recurrent hernia with eventration of the previously placed mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
|
|
Event Description
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent recurrent hernia on (b)(6) 2020 during which the surgeon noted recurrent hernia with eventration of the previously placed mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|