FDA Adverse Event
Injury
Summary report: N
4.5 CM ANTERIOR, EPISTAXIS
MDR report key: 1651508
·
Received April 1, 2010
Report
- Report Number
- 2951580-2010-00032
- Event Type
- Injury
- Date Received
- April 1, 2010
- Date of Event
- March 2, 2010
- Report Date
- April 1, 2010
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- EMX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT RETURNING FOR EVAL. A FOLLOW-UP REPORT WILL BE COMPLETED ONCE A LOT HISTORY REVIEW IS COMPLETED.
Description of Event or Problem · 1
ON (B) (6) 2010, THE PT UNDERWENT A NASAL SEPTOPLASTY AND AN ARTHROCARE 4.5 CM ANTERIOR, EPISTAXIS DEVICE WAS USED POST-OPERATIVELY. THE PT WAS DISCHARGED FROM THE HOSPITAL THE MORNING AFTER THE OPERATION WITH NO APPARENT ABNORMALITIES. THE DEVICE WAS REMOVED FROM THE PT 24 HOURS AFTER THE OPERATION. AFTER 48 HOURS HE WAS RE-ADMITTED WITH SUBMUCOSAL INFLAMMATION WITH FEVER AND SEDIMENTATION WITH PAIN. THE PT'S NOSE WAS CLEANED AND ANTIBIOTICS WERE ADMINISTERED. THE PT IS BETTER. THE PT'S NOSE IS HEALING AND HE CAN NOW BREATHE NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.5 CM ANTERIOR, EPISTAXIS | BALLOON, EPISTAXIS | EMX | ARTHROCARE CORP. | 2008-01-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization |