MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; HEATED MITTS

Model Number JBHM

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 01/26/2019

Event Type  Injury  

Manufacturer Narrative

On 04/5/2019 - we have received the product on 3/19/2019 and is currently under investigation.

Event Description

(b)(6) 2019 - the consumer claims her client at a salon stated the product malfunctioned and resulted in a 1st degree burn on the clients hand.The product was also burned.Medical attention was received.

Manufacturer Narrative

On 04/5/2019 - we have received the product on 3/19/2019 and is currently under investigation.On 4/25/2019 - the investigation has been complete.Below is the manufacturers narrative: device could not be tested as it was received in a non-working condition.As seen by the pictures included in report, the unit's line cord had ruptured causing the electric circuit to change.This change caused excessive heating on both heating mitts.Per instructions, the unit should be inspected prior to use.If any damage to the unit is seen, the unit should be discarded.In a high use condition that beauty shops generate, the inspection is very important.This issue was caused by insufficient inspection and continued use after it had become dangerous to use.

Event Description

On 4/5/2019 - the consumer claims her client at a salon stated the product malfunctioned and resulted in a 1st degree burn on the clients hand.The product was also burned.Medical attention was received.

• Brand Name: CONAIR CORPORATION
• Type of Device: HEATED MITTS
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 8487090
• MDR Text Key: 141061298
• Report Number: 1222304-2019-00010
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108174222
• UDI-Public: 74108174222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JBHM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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