MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-03 for SOLTRON XXL110 NA manufactured by Jk Products Gmbh.
[15777822]
Customer exited tanning bed putting their foot on a decorative part causing it to break and causing a small cut on their foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615023-2012-00010 |
| MDR Report Key | 2700564 |
| Report Source | 06,07 |
| Date Received | 2012-08-03 |
| Date of Report | 2012-08-03 |
| Date of Event | 2012-07-30 |
| Date Mfgr Received | 2012-07-30 |
| Device Manufacturer Date | 2011-11-17 |
| Date Added to Maude | 2012-11-26 |
| 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 Street | ROTTBITZER STRASSE 69 |
| Manufacturer City | BAD HONNEF 53604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 53604 |
| Manufacturer Phone | 2682700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLTRON |
| Generic Name | BLUEBERRY BLUES |
| Product Code | LEJ |
| Date Received | 2012-08-03 |
| Model Number | XXL110 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| 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 | BAD HONNEF 53604 GM 53604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-03 |