MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-03-04 for KING OF HEARTS EXPRESS DEV015 LR075 manufactured by Lifewatch Services, Inc..
[1434422]
Pt received burns from the electrodes along with her device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3027765-2010-00006 |
| MDR Report Key | 1633680 |
| Report Source | 04 |
| Date Received | 2010-03-04 |
| Date of Report | 2009-12-28 |
| Date of Event | 2009-12-21 |
| Date Mfgr Received | 2009-12-28 |
| Date Added to Maude | 2010-09-10 |
| 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 | MARIKAY MENARD |
| Manufacturer Street | 10255 W HIGGINS RD, STE 110 O'HARE INTERNATIONAL CTR II |
| Manufacturer City | ROSEMONT IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8478132977 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KING OF HEARTS EXPRESS |
| Generic Name | RECORDER, MEDICAL TAPE, MEDICAL |
| Product Code | DXH |
| Date Received | 2010-03-04 |
| Model Number | DEV015 |
| Catalog Number | LR075 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES, INC. |
| Manufacturer Address | ROSEMONT IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-04 |