MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-02-14 for ENSEKIGAISEN ONNETSUKI ("ONNETSU") M1-01 manufactured by Mitsui Onnetsu Co..
[17396944]
In a lawsuit, the estate of (b)(6) alleges that his death was caused by an infection caused by a burn caused by his home health care aide's personal use (it was not part of his prescribed care) of the onnetsu device while massaging him on his remaining leg (his other had been amputated due to diabetes). The aide has testified that she did not use the device on his leg and that wherever she used it on his body, she used it properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004057530-2011-00001 |
| MDR Report Key | 1988256 |
| Report Source | 99 |
| Date Received | 2011-02-14 |
| Date of Report | 2009-04-29 |
| Date of Event | 2007-05-28 |
| Date Facility Aware | 2009-06-01 |
| Report Date | 2011-02-04 |
| Date Added to Maude | 2011-11-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSEKIGAISEN ONNETSUKI ("ONNETSU") |
| Generic Name | INFRARED THERAPEUTIC HANDHELD MASSAGER |
| Product Code | ISA |
| Date Received | 2011-02-14 |
| Model Number | M1-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITSUI ONNETSU CO. |
| Manufacturer Address | MURAMATSU BID 4F 2-2-10 SHINBASHI HIGASHI MINATOKU-TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-02-14 |