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

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/31/2011

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.No medical report or medical history of the user was provided to the investigation.No causal link between the user and the device can be established.This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.The date of event provided is a best estimate by the manufacturer based on information received.

Event Description

Bio-medical research ltd.Was notified by it's distributor of a complaint regarding the system abs (model and serial number unknown).The customer purchased the device in (b)(6) 2011 and had used it for approximately 10 times, at 30-60 minutes per session.The customer has stated that the device felt uncomfortable around the end of (b)(6) of the same year and had consulted with their physician.The customer was subsequently diagnosed with a broken rib and required hospitalization.

• Brand Name: SLENDERTONE ABS
• 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: 5382718
• MDR Text Key: 36494591
• Report Number: 8020867-2015-00011
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2011
• 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): Hospitalization