MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-02-10 for RAPID RHINO NASAL CATHETER RR750 manufactured by Applied Therapeutics Ltd.
[459746]
In 2005, the patient was treated with a nasal dressing following sinus surgery. One day following treatement, the patient reported that the nasal dressing had fallen into the back of his throat causing the patient to choke and, subsequently, to remove the nasal dressing prior to returning to the hosp. The physician confirmed the nasal dressing had been removed and no patient injury has resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004063246-2006-00001 |
| MDR Report Key | 677006 |
| Report Source | 07 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-06 |
| Date of Event | 2005-12-01 |
| Date Mfgr Received | 2006-01-03 |
| Date Added to Maude | 2006-02-21 |
| 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 | BRUNO PROTHRO |
| Manufacturer Street | 680 VAQUEROS AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4087360224 |
| Manufacturer G1 | * |
| Manufacturer Street | 128 STATION ROAD |
| Manufacturer City | GLENFIELD LE38BR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE3 8BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID RHINO NASAL CATHETER |
| Generic Name | EPISTAXIX BALLOON |
| Product Code | EMX |
| Date Received | 2006-02-10 |
| Model Number | NA |
| Catalog Number | RR750 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 666290 |
| Manufacturer | APPLIED THERAPEUTICS LTD |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 8BR |
| Baseline Brand Name | RAPID RHINO NASAL CATHETER |
| Baseline Generic Name | EPISTAXIX BALLOON |
| Baseline Model No | NA |
| Baseline Catalog No | RR750 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-02-10 |