MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-20 for RAPID RHINO NASAL CATHETER UNK manufactured by Arthrocare Uk Ltd.
[442337]
On march 12, 2006, the pt was treated with a nasal dressing. One hour after placement of nasal dressing, it was reported the pt began bleeding and vomiting which caused the nasal catheter to clip to the back of the pt's throat. The physician removed the nasal dressing and stopped the pt's bleeding. There was no reported pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004063246-2006-00003 |
| MDR Report Key | 704335 |
| Report Source | 07 |
| Date Received | 2006-04-20 |
| Date of Report | 2006-04-19 |
| Date of Event | 2006-03-12 |
| Date Mfgr Received | 2006-03-16 |
| Date Added to Maude | 2006-04-28 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUCE PROTHRO |
| Manufacturer Street | 680 VAQUEROS AVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4087360224 |
| Manufacturer G1 | ARTHROCARE UK LTD |
| Manufacturer Street | 120 STATION RD |
| Manufacturer City | GELNFIELD LE38BR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE3 8BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RHINO NASAL CATHETER |
| Generic Name | ESPISTAXIS BALLOON |
| Product Code | EMX |
| Date Received | 2006-04-20 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 693421 |
| Manufacturer | ARTHROCARE UK LTD |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 8BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-20 |