Catalog Number CHG020 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Swelling/ Edema (4577)
|
Event Date 04/14/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
|
|
Event Description
|
It was reported the patient experienced material sensitivity post operatively and there will be a second surgery performed to remove the implants.
|
|
Event Description
|
It was reported the patient experienced material sensitivity post operatively and there will be a second surgery performed to remove the implants.
|
|
Manufacturer Narrative
|
The device was not returned for evaluation; however, the event can be confirmed as the surgeon required documents for fda compassionate use of device approval.
|
|
Search Alerts/Recalls
|