MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for ERGOLINE PRESTIGE 1400 manufactured by Jk Products Gmbh.
[114026496]
After use of the device indicated, the user reported smoke coming from the housing of the shoulder tanner bulb. In an attempt to identify the source of the smoke the manager of the salon compromised the housing by pushing in on the glass, resulting in a small flame starting where the glass separated from the housing. The small flame was quickly extinguished without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615023-2018-00001 |
| MDR Report Key | 7679344 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-06-15 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-07-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN HART |
| Manufacturer Street | 411 WEST WASHINGTON, SUITE B |
| Manufacturer City | JONESBORO AR 72401 |
| Manufacturer Country | US |
| Manufacturer Postal | 72401 |
| Manufacturer Phone | 8702682862 |
| Manufacturer G1 | JK PRODUCTS GMBH |
| Manufacturer Street | ROTTBITZER STRASSE 69 |
| Manufacturer City | BAD HONNEF, NORDRHEIN-WESTFALEN 53604 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 53604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ERGOLINE |
| Generic Name | TANNING BED |
| Product Code | LEJ |
| Date Received | 2018-07-11 |
| Model Number | PRESTIGE |
| Catalog Number | 1400 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS GMBH |
| Manufacturer Address | ROTTBITZER STRASSE 69 BAD HONNEF, NORDRHEIN-WESTFALEN 53604 GM 53604 |
| Brand Name | ERGOLINE |
| Generic Name | TANNING BED |
| Product Code | LEJ |
| Date Received | 2018-07-11 |
| Model Number | PRESTIGE |
| Catalog Number | 1400 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JK PRODUCTS GMBH |
| Manufacturer Address | ROTTBITZER STRASSE 69 BAD HONNEF, NORDRHEIN-WESTFALEN 53604 GM 53604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |