MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-08-13 for THERMOPHORE HEATING PAD manufactured by Battle Creek Equipment.
[21965611]
Customer called and stated the switch sparks and her pillow caught fire.
Patient Sequence No: 1, Text Type: D, B5
[22305759]
Despite providing a pre-paid return service label, the product in question has not been returned as of the date of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811605-2014-00170 |
| MDR Report Key | 4034931 |
| Report Source | 04,06 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-13 |
| Date of Event | 2014-07-16 |
| Date Added to Maude | 2014-08-25 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDY NEWSOME |
| Manufacturer Street | 702 SOUTH REED STREET |
| Manufacturer City | FREMONT IN 46737 |
| Manufacturer Country | US |
| Manufacturer Postal | 46737 |
| Manufacturer Phone | 2699626181 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOPHORE HEATING PAD |
| Generic Name | ELECTRIC MOIST HEAT PACK |
| Product Code | IMA |
| Date Received | 2014-08-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BATTLE CREEK EQUIPMENT |
| Manufacturer Address | FREMONT IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-13 |