MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HAND MASSAGER

Model Number HM11

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017 - to date, we have not received the product.We have contact the consumer request her mailing address.As of now the consumer has not provided the mailing address.

Event Description

On (b)(6) 2017 - the consumer claims that the product was purchased for her cat.The product emitted and odor and was smoking.Consumers contact information was not provided as the complaint was sent via email.

Manufacturer Narrative

On (b)(6) 2017 - we requested the device be returned to the manufacturer.To date, we have not received the device.On (b)(6) 2018 - the device was returned to the manufacturer.Investigation is in progress.Manufacturers narrative: on visual inspection, the line cord was broken.The break happened just outside the strain relief.Once repaired the unit was tested and found to work as designed.During use, the line cord is flexed many times.During the flex stage, the strain relief provides protection related to twists and bending.The history of our strain relief and no other consumer complaints would suggest it is working properly under normal use and that this case is abnormal.Seems the line cord was abused as there is significant wear at a specific location.Ul requires extensive testing related to the line cord flex - which we comply with.Not knowing the use patterns of this consumer reduces the chances of modifications with success.

Event Description

On (b)(6) 2017 - the consumer claims that the unit blew up after plugging the cord in the outlet.The consumer received burn their her thigh and her couch and pillow was caught on fired.Medical attention was not received.

• Brand Name: CONAIR
• Type of Device: HAND MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 7005886
• MDR Text Key: 92603753
• Report Number: 1222304-2017-00035
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HM11
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR