MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-04-22 for HEXAPOD P10602-128 manufactured by Medical Intelligence Medizintechnik Gmbh.
[833974]
The pt fell from the table on the hexapod and injured himself. He was attempting to get off of the table and due to the height had to step onto the step stool. He misstepped and fell, bruising his knees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710332-2008-00001 |
| MDR Report Key | 1033068 |
| Report Source | 08 |
| Date Received | 2008-04-22 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-03-11 |
| Date Mfgr Received | 2008-03-17 |
| Device Manufacturer Date | 2007-04-16 |
| Date Added to Maude | 2010-02-03 |
| 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 Street | ROBERT-BOSCH-STRASSE 8 |
| Manufacturer City | SCHWABMUNCHEN 86830 |
| Manufacturer Country | GM |
| Manufacturer Postal | 86830 |
| Manufacturer Phone | 4982329692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEXAPOD |
| Generic Name | RT COUCHTOP (IBEAM 14) |
| Product Code | JAI |
| Date Received | 2008-04-22 |
| Model Number | NA |
| Catalog Number | P10602-128 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Address | SCHWABMUNCHEN 86830 GM 86830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-22 |