MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-08 for ERGOLINE 1100 manufactured by Jk Products Gmbh.
[3391733]
Claimant alleges bed caught fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615023-2013-00001 |
| MDR Report Key | 3057351 |
| Report Source | 06 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-01 |
| Date of Event | 2013-03-31 |
| Date Mfgr Received | 2013-04-01 |
| Date Added to Maude | 2013-04-15 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LATEEF KHAN |
| Manufacturer Street | RITTBITZER STRASSE 69 |
| Manufacturer City | BAD HONNEF 53604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 53604 |
| Manufacturer Phone | 9351130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGOLINE |
| Generic Name | PRESTIGE 1100 |
| Product Code | LEJ |
| Date Received | 2013-04-08 |
| Model Number | 1100 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-04-08 |