MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-18 for 8CM ANTERIOR/POSTERIOR NASAL DRESSING RR 800 manufactured by Arthrocare Corp..
[20995381]
This physician has been using arthrocare rapid rhino rr 800 products since 2006. For the past two years, however, he has noticed that after removing the device there have been local, granulating, partly fibrous, alterations in the mucous membrane, some of which have led to membrane decay. In some cases, this has subsequently led to septum perforations. The physician did not provide any info about any one specific incident.
Patient Sequence No: 1, Text Type: D, B5
[21198055]
No individual incident date info was provided by the physician, so the date of occurrence is approximated as the date of incident on the arthrocare form filled out by the physician. The device is not returning for evaluation. A follow-up report will be completed once a lot history review is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2009-00130 |
| MDR Report Key | 1565287 |
| Report Source | 04 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-12-18 |
| Date of Event | 2009-11-05 |
| Date Added to Maude | 2011-03-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VALERIE DEFIESTA-NG |
| Manufacturer Street | 680 VAQUEROS AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4087360224 |
| 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 | 8CM ANTERIOR/POSTERIOR NASAL DRESSING |
| Generic Name | GEL KNIT REMOVABLE DRESSINGS |
| Product Code | EMX |
| Date Received | 2009-12-18 |
| Catalog Number | RR 800 |
| Lot Number | 2007-12 03 |
| 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 | 680 VAQUEROS AVE. SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-18 |