MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HAND MASSAGER

Model Number HM40F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017 - we have requested the device be returned to the manufacturer.To date, the device has not been returned.

Event Description

On (b)(6) 2017 - per the consumers attorney, the consumer burnt their hand while in use of the product.The consumer is currently going through treatment.

Manufacturer Narrative

(b)(4) 2017 - we have requested the device be returned to the manufacturer.To date, the device has not been returned.On 12/15/2017 - manufacturers narrative: this product was temperature and performance tested in the lab using calibrated ul test equipment while being operated according to the instruction booklet.The product performed properly and within the allowable temperature specs (see attached test record sheet and ib with highlighted warnings relating to possible burns if not properly operated).The product was also tested by placing my own hand in the unit in accordance with the ib and let run until water reservoir was completely empty (approx 20+ minutes).No burns were experienced while using it or the following day.The product was found to be operating properly when it was tested in the lab using calibrated ul test equipment and with actual hands.There are warnings in the ib that instruct the user how to use the product and how to avoid burns.The user apparently did not use the product properly or according to the ib and / or taken the necessary precautions to prevent burns.

Event Description

(b)(6) 2017 - per the consumers attorney, the consumer burnt their hand while in use of the product.The consumer is currently going through treatment.

• 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: 6989956
• MDR Text Key: 90651074
• Report Number: 1222304-2017-00032
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 10074108342256
• UDI-Public: (01)10074108342256(10)1016SR2(11)161001
• 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: 09/29/2017

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: No Information
• Device Model Number: HM40F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR