MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-03 for RAPID RHINO 750 EPISTAXIS DEVICE RR 750 manufactured by Arthrocare Corporation.
[15013907]
It was reported that one month after an epistaxis procedure using rapid rhino 750 epistaxis device, the pt presented with inflammatory reactive mucous membrane, clotting in the anterior nose and discoloration of the membrane. The doctor is unsure whether this was caused by the rapid rhino device, or something else. No further information was provided concerning the treatment of this issue; however no further complications have been reported regarding this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2013-00271 |
| MDR Report Key | 3213962 |
| Report Source | 06 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-06 |
| Date of Event | 2013-05-08 |
| Date Mfgr Received | 2013-06-05 |
| Date Added to Maude | 2013-07-10 |
| 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 | WENDY LAIRD |
| Manufacturer Street | 7000 W WILLIAM CANNON DR, BLDG 1 BUILDING ONE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585933 |
| 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 750 EPISTAXIS DEVICE |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2013-07-03 |
| Catalog Number | RR 750 |
| 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. Other | 2013-07-03 |