MAUDE Adverse Event Report: CONAIR CORP. TOUCH N TONE MASSAGER WITH MAGNET ATTACHMENT; HM11M

Model Number HM11M

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/26/2013

Event Type  Other  

Event Description

Consumer claims she was burned from the cord being damaged and also she had the unit off on her bed and when she rolled over she must have hit the switch and it turned on, burning her left upper leg.

Manufacturer Narrative

In testing now.Will resubmit to fda and send updated info at a later date.

• Brand Name: TOUCH N TONE MASSAGER WITH MAGNET ATTACHMENT
• Type of Device: HM11M
• Manufacturer (Section D): CONAIR CORP.; 1 cummings point rd.; stamford CT 06904
• Manufacturer (Section G): CONAIR CORP.; 1 cummings point rd.; stamford CT 06904
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06904 ; 2033519469
• MDR Report Key: 3588188
• MDR Text Key: 17260629
• Report Number: 1222304-2014-00003
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/26/2013

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: HM11M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2013
• Initial Date FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR