MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-24 for THERATHERM MOIST HEAT 1032 manufactured by Shian Ja Meei Enterprise Co., Ltd..
[1006341]
Patient was using the theratherm electric moist heating pad. She claimed the product timer turned it off, and she laid it on her leather sofa. When she came back into the room, she claimed the heating pad had turned itself on, and was smoldering the sofa.
Patient Sequence No: 1, Text Type: D, B5
[8220950]
The controller functions were tested with no deficiencies noted. Unit shut off when set time expires and the display goes blank, pad does not continue to heat and does not turn back on. Controller case was examined, and was not damaged. I. R. Temperature of controller was evaluated against controlled temperatures and no deficiencies were noted. The controller shuts power to heater off at 127 f. Controller was cycled several times and no malfunctions occur. Both sides of the outer cover are scorched and blackened near the sewn on label cord from controller to the pad is discolored a dirty pinkish hue. While no evidence of malfunction was identified, unit does appear to have undergone a scorch situation so mdr filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00381 |
| MDR Report Key | 1322456 |
| Report Source | 05 |
| Date Received | 2009-02-24 |
| Date of Report | 2007-04-23 |
| Date Mfgr Received | 2007-04-23 |
| 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 | 2007-04-30 |
| 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 |