MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-01-18 for 7.5 ANTERIOR/POSTERIOR RR 750 manufactured by Arthrocare Uk Ltd.
[813089]
In 2007, a clinical incident involving a rapid rhino device was reported to arthrocare corp. Two months earlier (exact date not provided), a rapid rhino nasal catheter was placed in each of the pt's nasal passage. Following removal of device from nasal passage, it was observed the pt's nasal passage showed evidence of necrotic septal perforation.
Patient Sequence No: 1, Text Type: D, B5
[8089397]
It was reported the device will not be returned for investigation. Since the device is not available for investigation, a lot history review was performed and the device was found to meet all prod specs. No conclusion can be made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004063246-2007-00003 |
| MDR Report Key | 983762 |
| Report Source | 08 |
| Date Received | 2008-01-18 |
| Date of Report | 2008-01-14 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-12-14 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2008-04-24 |
| 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 | 128 STATION ROAD |
| Manufacturer City | GLENFIELD 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 | 7.5 ANTERIOR/POSTERIOR |
| Generic Name | EPISTAXIS BALLOON |
| Product Code | EMX |
| Date Received | 2008-01-18 |
| Model Number | NA |
| Catalog Number | RR 750 |
| Lot Number | 2005-10 25 |
| ID Number | NA |
| Device Expiration Date | 2010-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 986535 |
| Manufacturer | ARTHROCARE UK LTD |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 8BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-18 |