MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-03 for ULTIMATE PHYSICAL THERAPY MASSAGER WITH DIGITAL LCD DISPLAY 390732448507 manufactured by Unk.
[17224159]
I bought an ultimate physical therapy massager item id 390732448507 from (b)(6). It was a gift for my son for christmas to help with a stiff neck. He had the pads stuck down on his trapezoid muscles on both sides of his neck and after five minutes, one of the pads burned his skin. It left a burn in the shape of the stimulator pad. He said he heard a sound like it was shorting out then it started hurting before he was able to remove it. I contacted (b)(6) and their response was: "please contact your doctor. " they had nothing to say about the unit, whether it could have been just one defective unit or if they had been having the same issue with other customers. Their response was bothersome, showing little or no concern about the product. Even more bothersome is the fact that they're selling something that is potentially dangerous. Injury, no first aid or medical attention received. Manufacturer: i don't know. It's from (b)(4). Purchase date: (b)(6) 2014. They have a 14 day return policy. I just found out about the incident. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040623 |
| MDR Report Key | 4491673 |
| Date Received | 2015-02-03 |
| Date Added to Maude | 2015-02-09 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIMATE PHYSICAL THERAPY MASSAGER WITH DIGITAL LCD DISPLAY |
| Generic Name | ULTIMATE PHYSICAL THERAPY MASSAGER |
| Product Code | ISA |
| Date Received | 2015-02-03 |
| Model Number | 390732448507 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | 4 MASSAGE PADS |
| Generic Name | PADS |
| Product Code | IRT |
| Date Received | 2015-02-03 |
| Model Number | 390732448507 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-03 |