MAUDE Adverse Event Report: MASSAGE BATTERY PACK; MASSAGE, THERAPEUTIC ELECTRIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seizures (2063)

Event Date 09/29/2018

Event Type  Injury  

Event Description

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.

• Brand Name: MASSAGE BATTERY PACK
• Type of Device: MASSAGE, THERAPEUTIC ELECTRIC
• MDR Report Key: 7934399
• MDR Text Key: 123079081
• Report Number: MW5080356
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 46 YR
• Patient Weight: 49