MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for THERMOPHORE 058 manufactured by Battle Creek Equipment.
[178744238]
Customer stated, " that they were lying in bed taking nap with their legs and feet on the bed warmer. After about an hour they woke up and had a blister on their leg. " customer claimed that pad caused a blister. Product has not been returned. Pictures were provided. No product was returned for investigation, however pictures were provided. Review of the provided pictures did not indicate any failures or abnormalities of the bed warmer. Review of reported events for the bedwarmer product found no reported events of burn injuries in a 2 year lookback. Without returned product further determinations cannot be made. Updated. Product was returned on 1/7/2020. Investigator observed no evidence of burn marks. An 8 hour test was conducted. The investigator determined there was no defect and all temperatures where within the expected ranges. Customer claim investigation was inconclusive, no trending of similar events within the last 2 years was found upon further review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832415-2020-10912 |
| MDR Report Key | 9676833 |
| Report Source | CONSUMER |
| Date Received | 2020-02-06 |
| Date of Report | 2019-11-13 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 058 |
| Lot Number | 00058015195 |
| 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 46737 US 46737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |