Model Number OSI200 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681); Insufficient Information (4580)
|
Event Date 09/28/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Device analysis report attached.This report is submitted on november 03, 2022.
|
|
Event Description
|
Per the clinic, the device was explanted on (b)(6) 2022 due to other medical reason.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.
|
|
Manufacturer Narrative
|
Per the clinic, it was reported that the patient experienced skin breakdown (date not reported).Additional information has been requested but it has not been made available as of the date of this report.This report is submitted on january 25, 2023.
|
|
Manufacturer Narrative
|
Per the clinic, the patient experienced a skin necrosis (specific date not reported) and was treated with oral antibiotics and topical ointment (specific date and duration not reported).This report is submitted on march,07,2023.
|
|
Manufacturer Narrative
|
Per the clinic, the patient experienced an infection at the site of breakdown (specific date not reported).This report is submitted on may 16, 2023.
|
|
Search Alerts/Recalls
|