MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for THERMOPHORE 055 manufactured by Battle Creek Equipment.
[187437955]
Customer stated, "she was sitting in the chair leaning back on the pad. The bottom corner of the pad became folded over. The spot on the pad became very hot and burnt her bottom. " customer claimed injury and sought medical attention. Product was not returned. Customer provided pictures of the unit. Based on the lot number provided by the customer the investigator determined the pad was 5 years and 10 months old. The investigator corroborated the customer statement of leaning on the pad and the pad being folded based on the pictures provided. The ifu states, "do not sit on, lie on, or crush pad. Avoid sharp folds" upon receipt of the product a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-11228 |
| MDR Report Key | 9865235 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-26 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Model Number | 055 |
| Lot Number | 0551414 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-23 |