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

Model Number 510

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

Patient Problem Pain (1994)

Event Date 04/05/2011

Event Type  Injury  

Manufacturer Narrative

Consumer did not provide a medical report.Device was evaluated and no failure was detected.Device was found to be operating within specification.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 pain in back after a few days of use.Doctor prescribed injections and advised her to stop using the product.After a few days, the pain stopped.She retried the device after a couple of months and she felt a pain in her back.

• Brand Name: SLENDERTONE FLEX
• 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: 5382446
• MDR Text Key: 36468023
• Report Number: 8020867-2015-00010
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2011

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
• Device Model Number: 510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2011
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2011
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 39 YR