Catalog Number UNKNOWN |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Ischemia (1942)
|
Event Date 09/09/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
The device is not returning to the manufacturer and we will not be able to evaluate the affected product.We continue in our efforts to follow up with the customer, if we obtain additional information we will send a supplemental report with additional findings.(b)(4).
|
|
Event Description
|
Prior to iab insertion and therapy, the patient developed a complication of limb ischemia after having significant and existing history of peripheral vascular disease in bilateral legs.
|
|
Manufacturer Narrative
|
Date received by manufacturer: date was not entered in the initial mdr.Date: received by manufacturer: 09/09/2016.
|
|
Event Description
|
Prior to iab insertion and therapy, the patient developed a complication of limb ischemia after having significant and existing history of peripheral vascular disease in bilateral legs.
|
|
Search Alerts/Recalls
|