MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for MASSAGE BATTERY PACK manufactured by Unk.
[123079081]
Seizure from massage battery pack pillow. Also, heated car seats and cooling seats in cars cause the same affect. But only on people who have wires in their necks. I am one of those people. Perhaps others that have metal implants or rods in legs. Warnings must happen immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080356 |
| MDR Report Key | 7934399 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-29 |
| Date of Event | 2018-09-29 |
| Date Added to Maude | 2018-10-04 |
| 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 | PATIENT |
| 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 | 0 |
| Brand Name | MASSAGE BATTERY PACK |
| Generic Name | MASSAGE, THERAPEUTIC ELECTRIC |
| Product Code | ISA |
| Date Received | 2018-10-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 1. Life Threatening; 2. Other | 2018-10-02 |