MAUDE Adverse Event Report: NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC BEACTIVE PLUS; ORTHOSIS, LIMB, FOR BACK PAIN

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Https://www.Getbeactiveplus.Ca/.Claims that the product is fda approved as a breakthrough pain device.Cannot find anything on fda website to substantiate this claim.Ordered the product and does not work at all.

• Brand Name: BEACTIVE PLUS
• Type of Device: ORTHOSIS, LIMB, FOR BACK PAIN
• Manufacturer (Section D): NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
• MDR Report Key: 16051268
• MDR Text Key: 306341042
• Report Number: MW5114005
• Device Sequence Number: 1
• Product Code: PMV
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White