MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-28 for RIFTON TRAM K310 manufactured by Rifton Equipment.
Report Number | 1319061-2020-00002 |
MDR Report Key | 9894833 |
Report Source | DISTRIBUTOR |
Date Received | 2020-03-28 |
Date of Report | 2020-03-28 |
Date Mfgr Received | 2020-02-27 |
Device Manufacturer Date | 2018-03-31 |
Date Added to Maude | 2020-03-28 |
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 | MR. TRAVIS SCOTT |
Manufacturer Street | 103 WOODCREST DRIVE |
Manufacturer City | RIFTON NY 12471 |
Manufacturer Country | US |
Manufacturer Postal | 12471 |
Manufacturer Phone | 8456587722 |
Manufacturer G1 | RIFTON EQUIPMENT |
Manufacturer Street | 103 WOODCREST DRIVE |
Manufacturer City | RIFTON NY 12471 |
Manufacturer Country | US |
Manufacturer Postal Code | 12471 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RIFTON TRAM |
Generic Name | TRANSFER AND MOBILITY DEVICE |
Product Code | FSA |
Date Received | 2020-03-28 |
Returned To Mfg | 2020-02-27 |
Model Number | K310 |
Catalog Number | K310 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | RIFTON EQUIPMENT |
Manufacturer Address | 103 WOODCREST DRIVE RIFTON NY 12471 US 12471 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-28 |