Model Number NEU_ENTERRA_INS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Erosion (1750)
|
Event Date 08/17/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Other applicable components are product id: neu_unknown_lead, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The healthcare provider (hcp) reported via the user facility that a revision was performed due to lead erosion.This event occurred (b)(6) 2017.The patient outcome was hospitalization.There were no further complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Product id: neu_unknown_lead, serial# unknown, product type: lead.Life threatening was removed as it was incorrectly applied to this event.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|