MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-05-21 for MAVIG TS1511-US manufactured by Mavig Gmbh.
[20928199]
Pt said he was moving the mavig shield when the arm broke away from its mount, and the assembly hit his knee causing him to seek treatment in the emergency room. He was later assigned "light duty" for the next four shifts.
Patient Sequence No: 1, Text Type: D, B5
[21130933]
Requested the device from the hospital but they believe it has been disposed of.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438931-2008-00001 |
| MDR Report Key | 1048934 |
| Report Source | 05,08 |
| Date Received | 2008-05-21 |
| Date of Report | 2008-05-19 |
| Date of Event | 2008-05-02 |
| Date Facility Aware | 2008-05-19 |
| Report Date | 2008-05-19 |
| Date Reported to Mfgr | 2008-05-19 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2009-05-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | STAHLGRUBERRING 5 |
| Manufacturer City | MUNICH 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer Phone | 9420960 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG |
| Generic Name | HANEL |
| Product Code | KPY |
| Date Received | 2008-05-21 |
| Model Number | TS1511-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-21 |