MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number WM52CS

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/04/2010

Event Type  Injury  

Event Description

(b)(6) is aunt of (b)(6).The customer claims to have medical bills for her nephew and had to replace the mattress.She claims cause is due to electrical cord of massager.

Manufacturer Narrative

Damaged upon receipt.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 3644792
• MDR Text Key: 4349117
• Report Number: 1222304-2014-00023
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/06/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WM52CS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/19/2011
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2010
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other