MAUDE Adverse Event Report: ELEALTCH ABDOMINAL MUSCLE BELT ABS WORKOUT 24"-47"; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 07/27/2022

Event Type  Injury  

Event Description

This product i bought it from amazon (b)(6).Brand: elealtch.It is an electrical muscle stimulator and have no fda certificated.And now i have skin problem with allergic as swollen and itchy after using it.Brand: elealtch.Fda safety report id# (b)(4).

• Brand Name: ELEALTCH ABDOMINAL MUSCLE BELT ABS WORKOUT 24"-47"
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• MDR Report Key: 15138234
• MDR Text Key: 297066696
• Report Number: MW5111202
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/28/2022

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female