MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-26 for NOT PROVIDED manufactured by Rotation Medical, Inc..
Report Number | 3009351468-2019-00103 |
MDR Report Key | 8830767 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-07-26 |
Date of Report | 2019-08-06 |
Date of Event | 2019-04-04 |
Date Mfgr Received | 2019-08-05 |
Date Added to Maude | 2019-07-26 |
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 | HOLLY TOPPING |
Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
Manufacturer City | AUSTIN TX 78735 |
Manufacturer Country | US |
Manufacturer Postal | 78735 |
Manufacturer Phone | 5123913905 |
Manufacturer G1 | ROTATION MEDICAL, INC. |
Manufacturer Street | 15350 25TH AVE. NO., SUITE 100 |
Manufacturer City | PLYMOUTH MN |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NOT PROVIDED |
Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
Product Code | OWY |
Date Received | 2019-07-26 |
Catalog Number | NOT PROVIDED |
Lot Number | NOT PROVIDED |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ROTATION MEDICAL, INC. |
Manufacturer Address | 15350 25TH AVE. NO., SUITE 100 PLYMOUTH MN |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-07-26 |