MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-08-18 for RAPID RHINO EPISTAXIS DEVICE manufactured by Arthrocare Corp..
[16723716]
It was reported that the patient presented with an unspecified epistaxis and was treated with a rapid rhino epistaxis device. After insertion, the patient reportedly began gagging and rebleeding. Upon examination, it was found that the left nasal pack had become displaced. Attempts to follow up on the patient's subsequent treatment and condition were unsuccessful. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[16939008]
The patient's age and gender have been requested but not received. Additionally, no catalog or lot number was provided; therefore, no manufacturing or expiration date could be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2011-00125 |
| MDR Report Key | 2223838 |
| Report Source | 01,06 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-08-05 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-08-05 |
| Date Added to Maude | 2011-08-30 |
| 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 EPISTAXIS DEVICE |
| Generic Name | NASAL BALLOON |
| Product Code | EMX |
| Date Received | 2011-08-18 |
| 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 | 2011-08-18 |