MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-07 for SUNDASH RADIUS 252 NA manufactured by Jk Products & Services.
[16520780]
We received information that one of our devices allegedly caught fire.
Patient Sequence No: 1, Text Type: D, B5
[16607566]
An 806 submitted to the (b)(4) district office of the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2311923-2015-00002 |
| MDR Report Key | 4946910 |
| Report Source | 06 |
| Date Received | 2015-07-07 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-07 |
| Date Mfgr Received | 2015-06-08 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2015-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CRAIG |
| Manufacturer Street | 1 WALTER KRATZ DRIVE |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal | 72401 |
| Manufacturer Phone | 8709351130 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2635-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNDASH |
| Generic Name | SUNTAN BED |
| Product Code | LEJ |
| Date Received | 2015-07-07 |
| Model Number | RADIUS 252 |
| Catalog Number | NA |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS & SERVICES |
| Manufacturer Address | JONESBORO AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-07 |