MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-08-18 for RAPID RHINO 752 EPISTAXIS DEVICE RR 752 manufactured by Arthrocare Corp..
[2265722]
Following a functional endoscopic sinus surgery (fess) and septoplasty procedure, it was reported the physician administered post-operatively a rapid rhino 752 epistaxis device (off-label) for the treatment/prevention of epistaxis. After insertion, the patient began choking as the left nasal pack slipped down the patient's throat. Once the nasal pack was removed, the patient ceased choking and no further intervention was required. Attempts to follow up on the patient's subsequent treatment and condition were unsuccessful. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[9401441]
Patient's age has been requested but not received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2011-00120 |
| MDR Report Key | 2223836 |
| Report Source | 01,06 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-06-01 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2011-06-01 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2011-08-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARISA PETERSON |
| Manufacturer Street | 680 VAQUEROS AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 5123585724 |
| 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 | RAPID RHINO 752 EPISTAXIS DEVICE |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2011-08-18 |
| Catalog Number | RR 752 |
| Lot Number | FZ14800-A |
| Device Expiration Date | 2012-04-01 |
| 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 | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-18 |