MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-12 for THERMOPHORE 156 manufactured by Battle Creek Equipment.
[182930728]
Customer stated, "notice a brown spot on her cover. Removed the cover, and found a burn hole in the heating pad. She can see the coil. Used pad in recliner, sitting up straight with pad behind back. " customer did not claim injury. Product was returned. Investigator observed discoloration of the unit, cover, thermostats, and a discolored hole. Additionally the investigator observed no evidence of burning. The investigator determined that the observed hole was a worn in hole. The investigator determined, along with the customers statement, that the use of the product on the recliner caused bunching of the lower part of the pad, which caused a worn hole and discoloration. Ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11094 |
| MDR Report Key | 9702639 |
| Report Source | CONSUMER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-16 |
| Date Added to Maude | 2020-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL GREEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOPHORE |
| Generic Name | THERMOPHORE |
| Product Code | IRT |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 156 |
| Lot Number | 00156115182 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BATTLE CREEK EQUIPMENT |
| Manufacturer Address | 702 S REED RD FREMONT, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |