MAUDE Adverse Event Report: THE BRIDGE EAR DEVICE FOR OPIOD WITHDRAWAL; STIMULATOR, ELECTRO-ACUPUNCTURE

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  No Answer Provided  

Event Description

Pt given the "bridge device" for opioid withdrawal with no evidence of efficacy, and then left real treatment due to "i have the bridge.".

• Brand Name: THE BRIDGE EAR DEVICE FOR OPIOD WITHDRAWAL
• Type of Device: STIMULATOR, ELECTRO-ACUPUNCTURE
• MDR Report Key: 7352342
• MDR Text Key: 103003718
• Report Number: MW5075971
• Device Sequence Number: 1
• Product Code: BWK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 82