|
Model Number 3772 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fever (1858); Fluid Discharge (2686); Implant Pain (4561)
|
Event Date 06/22/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|
|
Event Description
|
It was reported that patient experienced pain, pus at the ipg site and fever.Infection was rule out and the wound was disinfected.Reportedly, the issue was resolved.
|
|
Manufacturer Narrative
|
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|
|
Search Alerts/Recalls
|
|
|