MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD SLENDERTONE BOTTOM S7; POWERED MUSCLE STIMULATOR

Model Number 396

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

Patient Problem Neuropathy (1983)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

Consumer reported developing sciatica pain after using the device.Her chiropractor advised she has been treating the consumer since (b)(6) 2015 for an unspecified condition.She also advised the hypertonicity in her right piriformis muscle was evident along with pain in the sciatic nerve and that is was possible the use of the device was causing the buttock muscle to become hypertonic and irritate the surrounding nerves.Testing of the device showed the device was operating as intended and no issue could be found.A review of the device history record for the device showed no major issues during manufacture.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer reported developing sciatica on her right hand side from mid buttock down her leg.She has been using the unit 3 times a week for 3 weeks, the pain goes away when she stops using the unit.The pain is on one side only.

• Brand Name: SLENDERTONE BOTTOM S7
• 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: 5382473
• MDR Text Key: 36470006
• Report Number: 8020867-2015-00028
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K072294
• 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: 11/23/2015

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: 396
• Device Catalogue Number: 0396-2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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