MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-09-01 for MAVIG 4775768 manufactured by Mavig, Gmbh.
[1151084]
Before the start of an exam, the cardiologist positioned the lead shield when support arm broke at the column joint and sheared off, striking the doctor on the head requiring medical attention and stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438931-2009-00001 |
| MDR Report Key | 1478127 |
| Report Source | 99 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-08-28 |
| Date of Event | 2009-08-13 |
| Date Facility Aware | 2009-08-26 |
| Report Date | 2009-08-28 |
| Date Reported to Mfgr | 2009-08-26 |
| Date Added to Maude | 2010-04-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | STAHLGRUBERRING 5 |
| Manufacturer City | MUNICH 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer Phone | 498942096 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG |
| Generic Name | HANEL |
| Product Code | KPY |
| Date Received | 2009-09-01 |
| Model Number | 4775768 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG, GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-01 |