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

Model Number 399

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

Patient Problem Hernia (2240)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

Root cause of the complaint could not be established.No independent medical record or completed manufacturer medical questionnaire were provided to bio-medical research ltd as part of the investigation into the complaint.On review of the complaint, the senior clinical scientist (bio-medical research ltd.) advised that the user may have an underlying hernia or weakness with the abdominal wall prior to use.The device was tested and found to be operating within specification, however, the device usage history showed that no sessions had been performed using this device.Note: date of event is best estimate based on information received by bio-medical research ltd.

Event Description

Bio-medical research ltd.Was notified on (b)(6) 2015 of a complaint regarding the flex belt (part number 0399-5060).A female customer had reported that the belt felt uncomfortable and that it appeared that her navel had moved.Her doctor has diagnosed a hernia.No medical report has been supplied to bio-medical research ltd.The customer had previously used the belt up to 3 times per day for short periods.The customer had last used the belt approximately 4 months ago and cannot use the belt now.

• Brand Name: THE FLEX BELT
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD; parkmore business park, west; galway, H91 N HT7; EI H91 NHT7
• Manufacturer (Section G): BIO-MEDICAL RESEARCH LTD; parkmore business park, west; galway, H91 N HT7; EI H91 NHT7
• Manufacturer Contact: anne-marie keenan ; parkmore business park, west; galway, H91 N-HT7 ; EI H91 NHT7 ; 91774316
• MDR Report Key: 5382732
• MDR Text Key: 36493734
• Report Number: 8020867-2015-00022
• 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: 11/24/2015

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: 0399-5060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other