Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Rash (2033); Discomfort (2330)
|
Event Date 02/11/2015 |
Event Type
Injury
|
Event Description
|
It was further reported that the patient was stressed.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported by the patient they felt stiffness around their implant and rashes on their body.The patient reported having difficulty sleeping and could not get comfortable.The device was removed, during which the patient reported pain.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
|
|
Search Alerts/Recalls
|