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

Model Number 399 (X70)

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Rash (2033)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Device not returned by the consumer.Per the device labeling, this is a known adverse reaction as skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.

Event Description

Consumer reported skin puff up, turn into a rash and burned his stomach.Consumer applied antibacterial cream to affected area.It took approximately 3 weeks for the rash to disappear.

• Brand Name: THE 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: 5277164
• MDR Text Key: 33020308
• Report Number: 8020867-2015-00007
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K100320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2014

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 (X70)
• Device Catalogue Number: 0399-5060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR