MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; WAND MASSAGER

Model Number WM200XF

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

06/24/2021: we have requested the device be returned to the manufacturer.To date we have not recieved the device.

Event Description

(b)(6) 2021: the consumer claims to have received a burn under her right shoulder on the back side.The consumer received medical attention.

• Brand Name: CONAIR
• Type of Device: WAND MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT
• MDR Report Key: 12056852
• MDR Text Key: 258020629
• Report Number: 1222304-2021-00017
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WM200XF
• 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