MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

On 10/14/2016 - we have requested the product be returned to the manufacturer.To date, we have not received the product.

Event Description

On 10/4/2016 - the consumer alleges to have received a burn on his arm with in use the product.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd; stamford, CT 06902
• MDR Report Key: 6033136
• MDR Text Key: 57583339
• Report Number: 1222304-2016-00039
• 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
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 45 YR