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

Model Number 391

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/20/2012

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation and no medical report was provided as part of the investigation.Based on the limited information availble, no link could be established between the device and the adverse event reported at this time.Upon retrospective review, this issue was determined to reportable as an mdr.

Event Description

Consumer reported hearing a rib snap and felt severe pain as she was increasing the intensity of the device.Consumer stated to bmr that an x-ray completed by her doctor showed a rib was broken.

• Brand Name: SYSTEM ABS
• 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: 5382445
• MDR Text Key: 36468025
• Report Number: 8020867-2015-00012
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2012

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: 391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2012
• Initial Date FDA Received: 01/21/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other