MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-02-28 for RAPID RHINO NASAL CATHETER POSTERIOR EPISTAXIS RR 900 manufactured by Arthrocare Corp.
[20626909]
A clinical incident involving a rapid rhino device was reported to arthrocare corporation. The pt was treated with a nasal dressing. Reportedly the device had slipped and got lodged within the pt's lower trachea causing limited breathing and obstructing the airway severely, which caused severe distress to pt and near fatal injury. Although the pt recovered after the incident this has caused numerous panic attacks and severe psychological distress to the pt. The pt had reported that her airway was obstructed by something at 9 am on (b)(6) 2011 and was finding it difficult to talk or breath when she had been transfer to the hospital. The pt complained that she could not breath and that there was something sharp in her throat, it was visible to see that she was getting limited oxygen as she was unable to talk and her eyes were bulging. An ent physician tried to suction the device from the back of the pt's mouth to no avail, the pt started to lose consciousness upon where a crash team was called, however, a nearby anesthetist realized that it was the nasal pack which had lodged itself in the pt's throat and deflated the pack and removed it, freeing the pt's airway.
Patient Sequence No: 1, Text Type: D, B5
[20813581]
Pt's information has been requested and will be provided in a follow up report. Awaiting further information. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951580-2011-00032 |
| MDR Report Key | 2007764 |
| Report Source | 00,01 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-02-28 |
| Date of Event | 2011-01-02 |
| Date Mfgr Received | 2011-02-09 |
| Date Added to Maude | 2011-03-08 |
| 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 | 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 | RAPID RHINO NASAL CATHETER POSTERIOR EPISTAXIS |
| Generic Name | NONE |
| Product Code | EMX |
| Date Received | 2011-02-28 |
| Catalog Number | RR 900 |
| Lot Number | UNK |
| 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. Life Threatening | 2011-02-28 |