MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-19 for 7.5 ANTERIOR/POSTERIOR RR 750 manufactured by Arthrocare Uk Ltd.
[739851]
In 2007, a clinical incident involving a rapid rhino device was reported to arthrocare corp. The next day, a rapid rhino nasal catheter was place in each of the patient's nasal passages to alleviate nasal bleeding. The pt was observed overnight. On the event date, one of the two rapid rhino devices disassembled and the interior portion aspirated into the airway of the pt. The detached device was removed by the physician from the patients's airway. The second device placed in the opposite nasal passage remained in place. No reported pt injury.
Patient Sequence No: 1, Text Type: D, B5
[8014148]
The device was not returned for evaluation. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004063246-2007-00001 |
| MDR Report Key | 950997 |
| Report Source | 07 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-03-20 |
| Date of Event | 2007-03-20 |
| Date Added to Maude | 2007-11-23 |
| 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 VAQUEROZ AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4087360224 |
| Manufacturer G1 | ARTHROCARE U K LTD |
| Manufacturer Street | 128 STATION ROAD |
| Manufacturer City | GLENFIELD LE3HBR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE3 HBR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7.5 ANTERIOR/POSTERIOR |
| Generic Name | EPISTAXIS BALLOON |
| Product Code | EMX |
| Date Received | 2007-04-19 |
| Model Number | NA |
| Catalog Number | RR 750 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 922308 |
| Manufacturer | ARTHROCARE UK LTD |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 HBR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-19 |