MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR MASSAGER

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

We have request the product be returned for evaluation.We have not received the product to date.Device not returned to manufacturer.

Event Description

On (b)(6) 2016: the consumer alleges to receive a burn on her neck.The consumer received a burn after placing the product around her neck for an hour.

• Brand Name: CONAIR MASSAGER
• 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: 5510887
• MDR Text Key: 40688820
• Report Number: 1222304-2016-00017
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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