MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for MIDMARK 630 manufactured by Midmark.
[60689329]
The doctor at (b)(6) reported the 630 midmark universal procedure table moved with patient on the table during a procedure. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1523530-2016-00003 |
MDR Report Key | 6114224 |
Date Received | 2016-11-18 |
Date of Report | 2016-11-18 |
Date of Event | 2016-09-27 |
Date Mfgr Received | 2016-09-27 |
Device Manufacturer Date | 2014-08-08 |
Date Added to Maude | 2016-11-18 |
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 | JANE CARROLL |
Manufacturer Street | 60 VISTA DR. |
Manufacturer City | VERSAILLES OH 45380 |
Manufacturer Country | US |
Manufacturer Postal | 45380 |
Manufacturer G1 | MIDMARK |
Manufacturer Street | 60 VISTA DR. |
Manufacturer City | VERSAILLES OH 45380 |
Manufacturer Country | US |
Manufacturer Postal Code | 45380 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | MIDMARK |
Generic Name | 630 UNIVERSAL PROCEDURE TABLE |
Product Code | INQ |
Date Received | 2016-11-18 |
Model Number | 630 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MIDMARK |
Manufacturer Address | 60 VOSTA DR VERSAILLES OH 45380 US 45380 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2016-11-18 |