MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-03-30 for RAPID RHINO SINU KNIT DRESSING RR 600 manufactured by Applied Therapeutics Ltd..
[21951624]
In february 2006, a clinical incident involving an rapid rhino device was reorted to arthrocare corporation. On june 1, 2005, the patient was treated with a rapid rhino nasal dressing following endoscopic sinus surgery and septoplasty. Two weeks following treatment, the patient returned for a first postoperative visit and was reported to show good healing. In august 2005, a ct scan confirmed the patient had an infection of the right maxillary sinus. In january 2006, the patient returned for treatment of infection of the left nasal cavity. In february 2006, the patient was placed under anesthesia to remove all the residual nasal dressing. The nasal dressing material was found embedded in the nasal cavity and the area was debrided to remove the residual nasal dressing material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004063246-2006-00002 |
| MDR Report Key | 694490 |
| Report Source | 05 |
| Date Received | 2006-03-30 |
| Date of Report | 2006-03-29 |
| Date of Event | 2005-06-01 |
| Date Mfgr Received | 2006-02-20 |
| Date Added to Maude | 2006-04-04 |
| 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 AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4087360224 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| 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 SINU KNIT DRESSING |
| Generic Name | NASAL SPLINT |
| Product Code | EPP |
| Date Received | 2006-03-30 |
| Model Number | NA |
| Catalog Number | RR 600 |
| Lot Number | 2004 07 12G |
| ID Number | NA |
| Device Expiration Date | 2006-07-31 |
| 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 | 683617 |
| Manufacturer | APPLIED THERAPEUTICS LTD. |
| Manufacturer Address | 128 STATION ROAD GLENFIELD UK LE3 8BR |
| Baseline Brand Name | RAPID RHINO SINU KNIT DRESSING |
| Baseline Generic Name | NASAL SPLINT |
| Baseline Model No | NA |
| Baseline Catalog No | RR 600 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-30 |