MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-27 for RITTER 641-003 manufactured by Midmark Corp..
[4046834]
Physician was moving table and his leg became trapped underneath the table. Bruising was reported.
Patient Sequence No: 1, Text Type: D, B5
[11498051]
The product is not being returned for further evaluation. Product was evaluated on site. Operator indicated that obstruction was placed under unit during operation. User manual states "caution: be sure that personnel and equipment are clear of the table before activating any function. Failure to do so could result in personal injury. " no other error was detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2013-00017 |
| MDR Report Key | 3556802 |
| Report Source | 06,07 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-08-30 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-01-30 |
| 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 | CRAIG RAMMEL |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER |
| Generic Name | EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2013-09-27 |
| Model Number | 641-003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-09-27 |