MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-21 for MAVIG GMBH OT25U50 manufactured by Mavig Gmbh.
[21425617]
Arm broke off of the column and hit the dr in the back of the head, neck, and shoulder area and was knocked unconscious. Another physician stepped in to finish the procedure while he was taken for examination. They said the pt was also hit but no injuries were reported and further medical exam was not requested. No records were provided with the details of the dr's injuries. Referenced at (b)(4) under (b)(4). Waiting for customer to do its own investigation, then they will return it to us to do our investigation. Dates of use: about 8 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016828 |
| MDR Report Key | 1772188 |
| Date Received | 2010-07-21 |
| Date of Report | 2010-07-21 |
| Date of Event | 2010-07-15 |
| Date Added to Maude | 2010-07-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG GMBH |
| Generic Name | HANEL ARM |
| Product Code | KPY |
| Date Received | 2010-07-21 |
| Model Number | OT25U50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG GMBH |
| Manufacturer Address | STAHLGRUBERRING 5 MUNICH, BAVARIA 81829 81829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-07-21 |