|
Model Number 3772 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Seroma (2069); Post Operative Wound Infection (2446)
|
Event Date 04/13/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.During processing of this incident, attempts were made to obtain complete customer information.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2021-13608.Related manufacturer reference number: 1627487-2021-13610.It was reported that the patient was experiencing an infection, seroma, and keloid scarring, which were causing discomfort at the implant sites.As a result, the patient's system was explanted and the patient is recovering.
|
|
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. .
|
|
Manufacturer Narrative
|
Correction, d6b: date of explant provided.
|
|
Search Alerts/Recalls
|
|
|