MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for ZERO GRAVITY RADIATION PROTECTION SYSTEM manufactured by Contour Fabricators, Inc..
[65692105]
Patient Sequence No: 1, Text Type: N, H10
[65692106]
During repositioning of the zero gravity radiation protection system , the lead apron retention arm slid out from the retaining sleeve causing the system to free fall to the ground.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6275611 |
| MDR Report Key | 6275611 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-12-06 |
| Report Date | 2017-01-17 |
| Date Reported to FDA | 2017-01-17 |
| Date Reported to Mfgr | 2017-01-17 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZERO GRAVITY RADIATION PROTECTION SYSTEM |
| Generic Name | APRON, LEADED |
| Product Code | IWO |
| Date Received | 2017-01-25 |
| Device Availability | * |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTOUR FABRICATORS, INC. |
| Manufacturer Address | 14241 NORTH FENTON RD. FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |