MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD FLEX BELT; POWERED MUSCLE STIMULATOR

Model Number 399

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

Patient Problem Chest Pain (1776)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

Consumer reported suffering chest pain while using her flex belt device.Her cardiologist advised her she did not have coronary disease.No medical report was provided by the consumer.Device was evaluated and passed all testing.There were no faults found.Device history records for the device showed no major issues in the manufacturing process for this device.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer reported using the flex belt device one time for 7 minutes and began having severe chest pains.She turned off the unit and stated 'this resulted in a heart attack'.She visited her cardiologist and after being tested was advised she did not have coronary disease.The consumer requested a refund.

• Brand Name: FLEX BELT
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD; parkmore business park west; galway; galway, H91-N HT7; EI H91-NHT7
• Manufacturer (Section G): BIO-MEDICAL RESEARCH LTD; parkmore business park west; galway; galway, H91-N HT7; EI H91-NHT7
• Manufacturer Contact: andrea small ; parkmore business park west; galway; galway, H91 N-HT7 ; EI H91 NHT7 ; 91774350
• MDR Report Key: 5384859
• MDR Text Key: 36594057
• Report Number: 8020867-2015-00030
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• PMA/PMN Number: K100320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2015

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
• Device Model Number: 399
• Device Catalogue Number: 0390-5060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2015
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other