Model Number 90432 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Skin Infection (4544)
|
Event Type
Injury
|
Event Description
|
Per the clinic, the patient experienced an infection (suppuration) at the implant site (specific date not reported).Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported).Additional information has been requested but has not been made available as of the date of this report.
|
|
Manufacturer Narrative
|
This report is submitted on february 07, 2024.
|
|
Manufacturer Narrative
|
Correction: the previous mdr submitted on february 21, 2024 was filed inadvertently.No explantation has occurred.This report is submitted on march 22, 2024.
|
|
Manufacturer Narrative
|
Per the clinic, the device was explanted on (b)(6) 2024.This report is submitted on february 21, 2024.
|
|
Search Alerts/Recalls
|