MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-05-18 for RITTER 222-016 manufactured by Midmark Corp..
[2658255]
Facility claims the table lowered on its own by approximately 4 inches. Pt was on table. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[9930686]
The product is being return for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2012-00019 |
| MDR Report Key | 2588856 |
| Report Source | 06,07 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-05-18 |
| Date of Event | 2012-04-19 |
| Date Mfgr Received | 2012-04-19 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-09-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG RAMMEL |
| Manufacturer Street | 60 VISTA DR. |
| 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 | EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2012-05-18 |
| Model Number | 222-016 |
| 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 | 2012-05-18 |