MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-11-26 for RAPID RHINO 750 EPISTAXIS DEVICE RR 750 manufactured by Arthrocare Corp..
[15579863]
Following a functional endoscopic sinus surgery, the patient was treated post-operative with a rapid rhino 750 epistaxis device. Upon removal of the expistaxis, the physician noted damage to the patient's left nasal alar in the form of "notching. " according to the physician, the injury did not require any medical treatment or intervention. Simple observation to ensure proper healing was recommended by the physician. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[15869323]
The lot number of the above-referenced device was not available; therefore, no manufacturing or expiration date can be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2011-00174 |
| MDR Report Key | 2361746 |
| Report Source | 01,06 |
| Date Received | 2011-11-26 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2011-11-14 |
| Date Added to Maude | 2011-12-08 |
| 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 | 680 VAQUEROS AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| 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 750 EPISTAXIS DEVICE |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2011-11-26 |
| 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 CORP. |
| Manufacturer Address | SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-26 |