FDA Adverse Event
Injury
Summary report: N
RAPID RHINO 752 EPISTAXIS DEVICE
MDR report key: 2223836
·
Received August 18, 2011
Report
- Report Number
- 2951580-2011-00120
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- January 11, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- EMX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
PATIENT'S AGE HAS BEEN REQUESTED BUT NOT RECEIVED.
Description of Event or Problem · 1
FOLLOWING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND SEPTOPLASTY PROCEDURE, IT WAS REPORTED THE PHYSICIAN ADMINISTERED POST-OPERATIVELY A RAPID RHINO 752 EPISTAXIS DEVICE (OFF-LABEL) FOR THE TREATMENT/PREVENTION OF EPISTAXIS. AFTER INSERTION, THE PATIENT BEGAN CHOKING AS THE LEFT NASAL PACK SLIPPED DOWN THE PATIENT'S THROAT. ONCE THE NASAL PACK WAS REMOVED, THE PATIENT CEASED CHOKING AND NO FURTHER INTERVENTION WAS REQUIRED. ATTEMPTS TO FOLLOW UP ON THE PATIENT'S SUBSEQUENT TREATMENT AND CONDITION WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPID RHINO 752 EPISTAXIS DEVICE | BALLOON, EPISTAXIS | EMX | ARTHROCARE CORP. | FZ14800-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |