MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for JOOFO HEATING PAD FOR SOOTHING PAIN RELIEF manufactured by Unk.
[175049024]
Soft heat heating pad. The product is made by joofo and has an etl 5012740 listing. When i contacted etl the manufacture for this product is not listed as joofo and they are not authorized to put the listing on the box. The consumer bought the item on (b)(6) about 2 days ago. After turning it on they reported a burning smell in the home. As they were looking for the cause of the smell, the homeowner picked up the heating pad and it was so hot she burnt her fingers. It appeared to be shorting out internally and over heating a one location. The product is from (b)(4) and listed under joofo model #hp020. I have reached out to the state of (b)(6) fire marshal about risk of fire. I have also talked with the investigation unit at intertek because of the listing on the product is not from the manufacturing company they tested. I would list this is a huge fire risk. Joofo, unk location. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092145 |
| MDR Report Key | 9570725 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-09 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOOFO HEATING PAD FOR SOOTHING PAIN RELIEF |
| Generic Name | PAD, HEATING, POWERED |
| Product Code | IRT |
| Date Received | 2020-01-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |