MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-21 for SUNDASH 252 manufactured by Jk Products & Services, Inc..
[4649221]
Wiring in power harness shorted.
Patient Sequence No: 1, Text Type: D, B5
[12135685]
An 806 submitted to the (b)(4) district office of the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2311923-2014-00001 |
| MDR Report Key | 3899084 |
| Report Source | 06 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-04-21 |
| Date Mfgr Received | 2014-05-20 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2014-07-11 |
| 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 Contact | LATEEF KHAN |
| Manufacturer Street | 1 WALTER KRATZ DR. |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal | 72401 |
| Manufacturer Phone | 8709351130 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNDASH |
| Generic Name | RADIUS |
| Product Code | LEJ |
| Date Received | 2014-05-21 |
| Model Number | 252 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS & SERVICES, INC. |
| Manufacturer Address | JONESBORO AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-21 |