MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-05-22 for RAPID RHINO SINU KNIT DRESSING RR 600 manufactured by Arthrocare Uk Ltd.
[492778]
On april 19, 2006, a clinical incident involving a rapid rhino device was reported to arthrocare corporation. In 2005, the patient was treated with a nasal dressing following a sinus surgery. It was reported the patient has had recurrent infections during the six months following treatment with the nasal dressing.
Patient Sequence No: 1, Text Type: D, B5
[7780474]
A portion of the device was returned for evaluation. The sample received did not meet the material requirements for the device. A retention sample from the same lot was also analyzed and met the material requirement for the device. The instructions for use provides the following instructions at the postoperative visit. "any residual gel that has not dissolved or left the surgical site through normal outflow passages may be easily removed through gentle suction". Based on this information, it was concluded the device was not properly removed following the procedure. The event occurred due to user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004063246-2006-00004 |
| MDR Report Key | 728001 |
| Report Source | 05,06 |
| Date Received | 2006-05-22 |
| Date of Report | 2006-05-19 |
| Date of Event | 2005-06-15 |
| Date Mfgr Received | 2006-04-18 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2006-06-23 |
| 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 | ARTHROCARE INFORMATION |
| Manufacturer Street | 128 STATION ROAD |
| 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 SINU KNIT DRESSING |
| Generic Name | NASAL SPLINT |
| Product Code | EPP |
| Date Received | 2006-05-22 |
| Returned To Mfg | 2006-04-19 |
| 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 | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 716279 |
| Manufacturer | ARTHROCARE UK 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 | 2006-05-22 |