MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2009-02-24 for THERATHERM MOIST HEAT THERAPY 1030 manufactured by Shian Jia Meei Enterprise Co., Ltd..
[1006062]
The heating pad burnt the customer skin in a small place. The customer did not provide location of burn. The customer reported that she was 'fine' and that the pad just got too hot.
Patient Sequence No: 1, Text Type: D, B5
[8255756]
Product evaluation and testing showed that the product had been mis-used by allowing the pad to fold onto itself. The instructions warn against folding the device onto itself. Also, misuse from lying on the pad could cause the same results. The instructions warn against lying on the pad. The manufacturer of the product supplied a letter stating there has not been reported problems with the product like reported in this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00386 |
| MDR Report Key | 1322361 |
| Report Source | 04,08 |
| Date Received | 2009-02-24 |
| Date of Report | 2007-07-12 |
| Date Mfgr Received | 2007-07-12 |
| 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 | 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 THERAPY |
| Generic Name | IMA |
| Product Code | IMA |
| Date Received | 2009-02-24 |
| Model Number | 1030 |
| Operator | PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIAN JIA MEEI ENTERPRISE CO., LTD. |
| Manufacturer Address | TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-24 |