MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-09 for UT69 TABLE MOUNTED RADIATION SHIELDS UT6902-US manufactured by Mavig Gmbh.
[15555868]
The ut69table shield has a u profile that covers the shields support bar and the profile edges were sharp causing paper cut type injuries on the installer. (b)(6) did a quality check and found out that the manufacture did not burr (sand and polish) the edges which caused this issue. (b)(6) had the manufacture fix the issue and we went through and replaced all the defective profiles with ones that were burred and sanded so they had a smooth edge and did not cause any more cuts. The manufacturer of the u profiles detected that the problem came from a non sufficiently trained employee, has since increased his quality and training process and adapted a laser processed production.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017368 |
| MDR Report Key | 1833208 |
| Date Received | 2010-09-09 |
| Date of Report | 2010-09-09 |
| Date of Event | 2010-07-14 |
| Date Added to Maude | 2010-09-20 |
| 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 | UT69 TABLE MOUNTED RADIATION SHIELDS |
| Generic Name | UT69 |
| Product Code | KPY |
| Date Received | 2010-09-09 |
| Model Number | UT6902-US |
| Catalog Number | UT6902-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG GMBH |
| Manufacturer Address | STAHLGRUBERRING 5 MUNICH, BAVARIA 81829 GM 81829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-09 |