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

Model Number 398

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

Patient Problem Rash (2033)

Event Date 01/24/2013

Event Type  Injury  

Manufacturer Narrative

Returned device passed testing as per test requirements.Review of device history records at supplier site showed no major issues in the manufacturing process for that batch.No medical report was supplied by the consumer.Instruction manual dos and donts section indicates 'a small number of isolated skin reactions have been reported by people using muscle stimulation devices.'.Based on the limited information to hand, it appears the consumer may have suffered a known adverse reaction.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer used the abs belt 3 times and noticed itchy spots under the pads.After 3 weeks the spots turned brown and began to go away.Her doctor prescribed aqueous cream and ointment which did not help and so then prescribed steroids, antibiotic and piriton.

• Brand Name: SLENDERTONE 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: 5383256
• MDR Text Key: 36526168
• Report Number: 8020867-2015-00018
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K100320
• 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: 02/25/2013

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: 398
• Device Catalogue Number: 0398-2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2013
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other