MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2019-06-19 for RAPID RHINO UNKNOWN manufactured by Arthrocare Corp..
Report Number | 3006524618-2019-00301 |
MDR Report Key | 8711807 |
Report Source | CONSUMER,USER FACILITY |
Date Received | 2019-06-19 |
Date of Report | 2019-07-24 |
Date of Event | 2019-05-23 |
Date Mfgr Received | 2019-07-23 |
Date Added to Maude | 2019-06-19 |
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 | 3 |
Manufacturer Contact | JIM GONZALES |
Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
Manufacturer City | AUSTIN TX 78735 |
Manufacturer Country | US |
Manufacturer Postal | 78735 |
Manufacturer Phone | 5123585706 |
Manufacturer G1 | ARTHROCARE CORP. |
Manufacturer Street | 7000 W. WILLIAM CANNON |
Manufacturer City | AUSTIN TX 78735 |
Manufacturer Country | US |
Manufacturer Postal Code | 78735 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RAPID RHINO |
Generic Name | BALLOON, EPISTAXIS |
Product Code | EMX |
Date Received | 2019-06-19 |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
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 | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-06-19 |