MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR MASSAGER

Model Number WM52CS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 - we have requested the device be returned to the manufacturer for evaluation.To date, we have not received the device.

Event Description

On (b)(6) 2016 - the consumer alleges to have received a burn.The consumer admittingly fell asleep while in use of this product.The consumer claims to have a severe burn on stomach.Medical attention to be received.

Manufacturer Narrative

On 4/28/2016 - we have requested the device be returned to the manufacturer for evaluation.To date, we have not received the device.On 5/17/2016 - device has been received and is currently under evaluation.On 6/16/2016 - per manufacturers report, temperature and electrical testing was conducted and within the specifications.Per the original report, the consumer admittlingly fell asleep while in use of the product.Laying or sleeping while in use of the product is not recommended per the ib.

Event Description

On (b)(6) 2016 - the consumer alleges to have received a burn.The consumer admittingly fell as sleep while in use of this product.The consumer claims to have a severe burn on stomach.Medical attention to be received.

• Brand Name: CONAIR MASSAGER
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd; stamford, CT 06902
• MDR Report Key: 5659384
• MDR Text Key: 45320143
• Report Number: 1222304-2016-00023
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WM52CS
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 40 YR