MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for ERGOLINE CLASSIC 600 manufactured by Jk Products Gmbh.
| Report Number | 9615023-2019-00001 |
| MDR Report Key | 8966048 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-09-05 |
| Date of Event | 2017-08-17 |
| Date Facility Aware | 2019-08-08 |
| Date Mfgr Received | 2019-08-08 |
| Date Added to Maude | 2019-09-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUERGEN GERSTENMEIER |
| Manufacturer Street | ROTTBITZER STRASSE 69 |
| Manufacturer City | BAD HONNEF, NORDRHEIN-WESTFALEN 53604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 53604 |
| 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 | 2019-09-05 |
| Model Number | CLASSIC |
| Catalog Number | 600 |
| Lot Number | NA |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-05 |