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

Model Number 396

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

Patient Problem Rash (2033)

Event Date 11/01/2014

Event Type  Injury  

Manufacturer Narrative

No medical report was provided for this investigation.Testing was completed on the device and it was found to be operating within specification.A review of the device history records confirms that the device has met its manufacturing specifications.Adverse reactions of skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.This risk has been documented in the risk assessment and also user instructions for use of the device.' a small number of isolated skin reactions have been reported by people using muscle stimulation devices, including allergies, a prolonged reddening of the skin and acne'.This complaint has been reported as part of a retrospective review of complaints representing events that are mdr reportable.

Event Description

Bio-medical research ltd.Was notified on (b)(6) 2015, via email, of a complaint regarding the slendertone bottom device.A (b)(6) old female customer reported a rash after first using the device in (b)(6) 2014.The rash was located around the upper gel pads area.The customer stopped using the device for a couple of weeks and changed the pads.As soon as the she reused the device, the rash appeared.The customer visited her gp and was given an ointment to use on the areas affected (areas covered by the upper pads and one area under the lower right pad).The customer waited for the rash to disappear and started again in (b)(6) 2015 and the rash reappeared.The customer visited her gp on (b)(6) 2015 and was told to discontinue using the device and was given a cream to use for 2 weeks.The customer has used the ointment for 4 weeks and rash has disappeared.

• Brand Name: SLENDERTONE BOTTOM
• 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: 5382431
• MDR Text Key: 36468661
• Report Number: 8020867-2015-00027
• 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: 02/27/2015

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: 0396-2050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2015
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR