MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-04-01 for 4.5 CM ANTERIOR, EPISTAXIS RR 450 manufactured by Arthrocare Corp..
[15698190]
On (b) (6) 2010, the pt underwent a nasal septoplasty and an arthrocare 4. 5 cm anterior, epistaxis device was used post-operatively. The pt was discharged from the hospital the morning after the operation with no apparent abnormalities. The device was removed from the pt 24 hours after the operation. After 48 hours he was re-admitted with submucosal inflammation with fever and sedimentation with pain. The pt's nose was cleaned and antibiotics were administered. The pt is better. The pt's nose is healing and he can now breathe normally.
Patient Sequence No: 1, Text Type: D, B5
[15988772]
The device is not returning for eval. A follow-up report will be completed once a lot history review is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2010-00032 |
| MDR Report Key | 1651508 |
| Report Source | 08 |
| Date Received | 2010-04-01 |
| Date of Report | 2010-04-01 |
| Date of Event | 2010-03-02 |
| Date Mfgr Received | 2010-03-22 |
| Date Added to Maude | 2010-04-08 |
| 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 | 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 | 4.5 CM ANTERIOR, EPISTAXIS |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2010-04-01 |
| Catalog Number | RR 450 |
| Lot Number | 2008-01-04 |
| 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. Hospitalization | 2010-04-01 |