MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-11 for RAPID RHINO NASAL CATHETER RR 752 manufactured by Arthrocare Uk Ltd..
[526812]
On july 5, 2006, a clinical incident involving a rapid rhino device was reported to arthrocare corp. The pt underwent a nasal airway surgery for airway obstruction due to a grade 8/10 nasal allergy. On the same day of the procedure, the pt was reported to have experienced a choking sensation. The external nasal device appeared in situ. Upon examination of the pt's mouth, the physician reported a portion of the device, a "tampon sleeve" , was found hanging in the oropharynx area of the pt's throat and extending into the larynge pharynx just above the pt's vocal chords. No reported pt injury.
Patient Sequence No: 1, Text Type: D, B5
[7983022]
The device was not returned for eval. The lot history documentation was reviewed for this lot. The device history record review indicates all specs were met. No other similar complaints have been recorded for this lot. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004063246-2006-00005 |
| MDR Report Key | 771927 |
| Report Source | 05 |
| Date Received | 2006-08-11 |
| Date of Report | 2006-07-05 |
| Date of Event | 2006-05-10 |
| Date Mfgr Received | 2006-07-05 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2006-10-24 |
| 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 RD |
| 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 | RAPID RHINO NASAL CATHETER |
| Generic Name | EPISTAXIS BALLOON |
| Product Code | EMX |
| Date Received | 2006-08-11 |
| Model Number | NA |
| Catalog Number | RR 752 |
| Lot Number | 20040808G |
| ID Number | NA |
| Device Expiration Date | 2006-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 759706 |
| Manufacturer | ARTHROCARE UK LTD. |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 8BR |
| Baseline Brand Name | RAPID RHINO NASAL CATHETER |
| Baseline Generic Name | EPISTAXIS BALLOON |
| Baseline Model No | NA |
| Baseline Catalog No | RR 752 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-11 |