MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number WM200X

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

On 10/10/2017 - we received the device on 10/6/2017.The device evaluation is currently in progress.

Event Description

On (b)(6) 2017 - the consumer claims to have received a burn on his back and shoulder while in use of the product.

Manufacturer Narrative

We received the device on 10/6/2017.The device evaluation is currently in progress.Manufacturers narrative: the heated surface was allowed to run for 2 hours.There is no auto off but the instructions limit use time of heat to 3 minutes.Use time for massage is also limited to 15 min on any 1 muscle.After 2 hours of run time, the maximum temperature reached was 43c (109f).The maximum allowable touch temperature from underwriters laboratories (3rd party test lab) is 55c.We are well within the safety agency touch temperature.Skin sensitivity should always be checked prior to use.Medications and other health conditions can make the skin more sensitive.The temperature of the massager and the use time recommended would not produce any burns.If burns occurred, it was either used for a longer period of time then what is recommended and in addition - the users skin is obviously too sensitive for this device.Root cause: consumer misuse.Use time of 3 min with a temperature under 43 c would not cause a burn on normal skin types.

Event Description

On (b)(6) 2017 - the consumer claims to have received a burn on his back and shoulder while in use of the product.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd; stamford, CT 06902
• MDR Report Key: 6964555
• MDR Text Key: 89817272
• Report Number: 1222304-2017-00030
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WM200X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR