MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-03-13 for RAPID RHINO 550 EPISTAXIS DEVICE RR 550 manufactured by Arthrocare Corporation.
[2408294]
It was reported the patient presented with an epistaxis requiring urgent treatment. The physician reportedly attempted to treat the patient with a rapid rhino 550 epistaxis device; however, the balloon device failed to stay inflated. No additional information is available at this time. The manufacturer's follow-up attempts are underway in order to obtain additional information regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2012-00104 |
| MDR Report Key | 2492365 |
| Report Source | 01,06 |
| Date Received | 2012-03-13 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-02-20 |
| Date Mfgr Received | 2012-02-28 |
| Date Added to Maude | 2012-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRICIA UDOVICH |
| Manufacturer Street | 7000 W WILLIAM CANNON BLDG 1 |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE COSTA RICA |
| Manufacturer City | LA AURORA, HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RHINO 550 EPISTAXIS DEVICE |
| Generic Name | NASAL, BALLOON |
| Product Code | EMX |
| Date Received | 2012-03-13 |
| Catalog Number | RR 550 |
| Lot Number | FV34110-E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-13 |