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

Model Number 372

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling (2091)

Event Date 02/02/2014

Event Type  Injury  

Manufacturer Narrative

Consumer did not provide a medical report / evaluation.Device was returned for evaluation and passed testing as per the test requirements.Consumer suffered a known adverse skin reaction and this is documented in our user manuals for the use of the device.Upon retrospective review, this issue was determined to be reportable as an mdr.

Event Description

Consumer reported after using her product for 20 minutes, swelling started underneath the paddles of the unit and behind her ears.She took an antihistamine and the swelling gradually went down.The consumer suffers from underactive thyroid but has been using other slendertone product for years without any issues.

• Brand Name: SLENDERTONE FACE
• 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: 5383264
• MDR Text Key: 36527994
• Report Number: 8020867-2015-00023
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K103031
• 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: 02/03/2014

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: 372
• Device Catalogue Number: 0372-2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 01/21/2016
• 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: 40 YR