MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD SYSTEM ULTRA; POWERED MUSCLE STIMULATOR

Model Number 517

Device Problem Insufficient Information (3190)

Patient Problem Muscle Spasm(s) (1966)

Event Date 04/01/2012

Event Type  Injury  

Manufacturer Narrative

Consumer did not provide a medical report and returned her device to the place of purchase, therefore no testing could be completed on the device.Device history records could not be reviewed as no serial number for the device was available.Based on the limited information available, at this time, no link could be established between the device and the adverse event reported.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer reported she began shaking all over her body when using the unit.She went to the hospital and required muscle relaxing medication to recover.

• Brand Name: SYSTEM ULTRA
• 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: 5382447
• MDR Text Key: 36468041
• Report Number: 8020867-2015-00014
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2012

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: 517
• Device Catalogue Number: 0517-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2012
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other