MAUDE Adverse Event Report: ELECTROMEDICAL PRODUCTS INT'L ALPHA-STIM ; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

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

Patient Problems Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Date 10/22/2019

Event Type  Injury  

Event Description

My acupuncturist used alpha-stim on my earlobes for 20 min.During acupuncture treatment, i experienced intestinal spasms and bloating for 12 hours.Also insomnia, required 2 f/u acupuncture visits to alleviate symptoms.

• Brand Name: ALPHA-STIM
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): ELECTROMEDICAL PRODUCTS INT'L
• MDR Report Key: 9266356
• MDR Text Key: 165037473
• Report Number: MW5090831
• Device Sequence Number: 1
• Product Code: GZJ
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 49