MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; MASSAGER

Model Number WM200XF

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

Patient Problem Burn, Thermal (2530)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 we have requested the device be returned to the manufacturer.To date, we have not recieved the device.

Event Description

On (b)(6) 2020 - the cosumer claims to have burnt his leg while in use of the product.The cosumer received medical attention.

• Brand Name: CONAIR CORPORATION
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford,
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 10388030
• MDR Text Key: 202425521
• Report Number: 1222304-2020-00007
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 74108067180
• UDI-Public: 74108067180
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WM200XF
• Was Device Available for Evaluation?: 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: 50 YR