MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-05-21 for MAVIG 7728178 manufactured by Mavig Gmbh.
[874105]
Tech was moving the shield when the arm broke off and the shield assembly fell and struck her shoulder. She was sent for x-rays which returned negative. She reported a "golf-ball sized lump" that has healed. She says she has recovered fine.
Patient Sequence No: 1, Text Type: D, B5
[8017862]
Tammy said that the arm is no longer on site. Serial number info was not provided during initial reporting. Mavig cannot recover arm at this point.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438931-2008-00002 |
| MDR Report Key | 1048933 |
| Report Source | 99 |
| Date Received | 2008-05-21 |
| Date of Report | 2008-05-19 |
| Date of Event | 2008-04-02 |
| Date Added to Maude | 2010-04-06 |
| 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 | STAHLGRUBERRING 5 |
| Manufacturer City | MUNICH 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer Phone | 9420960 |
| Single Use | 0 |
| 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 | 7728178 |
| Device Availability | N |
| Device Age | DA |
| 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 |