MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-07-26 for RITTER 223 manufactured by Midmark Corp..
[2061733]
A patient was operating the table while the doctor was out of the room and lowered the table using the foot control. The patients foot became wedged between the drawer section and the floor. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[9214534]
The device operated as intended. There were no injuries reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00021 |
| MDR Report Key | 2194422 |
| Report Source | 06,07 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-07-25 |
| Date of Event | 2011-06-27 |
| Date Mfgr Received | 2011-06-27 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2012-05-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. P.O. BOX 286 |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-07-26 |
| Model Number | 223 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-26 |