MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2009-02-24 for THERATHERM MOIST HEAT 1032 manufactured by Shian Ja Meei Enterprise Co., Ltd..
[1006309]
Patient was using the theratherm electric moist heating pad, and claims that unit started a fire. Patient did not report any injury.
Patient Sequence No: 1, Text Type: D, B5
[8257334]
Unit was received wet in a bag. End opposite the power cord and insulation was burned. Temperature controller was tested and functioned. Further evaluation of the device was not possible, due to exposure of the device to large volumes of water. Cause of the event is unknown, but there is evidence of burning, so mdr malfunction is submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00380 |
| MDR Report Key | 1322455 |
| Report Source | 04,05 |
| Date Received | 2009-02-24 |
| Date of Report | 2007-05-29 |
| Date Mfgr Received | 2007-05-29 |
| Date Added to Maude | 2009-02-24 |
| 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 | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238707207 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATHERM MOIST HEAT |
| Generic Name | IMA |
| Product Code | IMA |
| Date Received | 2009-02-24 |
| Returned To Mfg | 2007-06-04 |
| Model Number | 1032 |
| Operator | PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIAN JA MEEI ENTERPRISE CO., LTD. |
| Manufacturer Address | TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-24 |