CONAIR MASSAGER WM25CS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-29 for CONAIR MASSAGER WM25CS manufactured by Conair Corp..

Event Text Entries

[18291373] Consumer claims to have burned his back while using the massager. He states that the unit felt very hot after approx five minutes. When he took it from his lower back it blistered right away. Consumer claims to have third degree burns.
Patient Sequence No: 1, Text Type: D, B5

[18534619] The consumer returned the unit to the retailer from whom it was originally purchased. We have reached out to the retailer and they will be contacting us upon locating the returned product.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1222304-2014-00047
• MDR Report Key: 4017260
• Report Source: 04
• Date Received: 2014-07-29
• Date of Report: 2014-07-09
• Date of Event: 2014-07-04
• Date Mfgr Received: 2014-07-09
• Date Added to Maude: 2014-08-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 1 CUMMINGS POINT RD.
• Manufacturer City: STAMFORD CT 06902
• Manufacturer Country: US
• Manufacturer Postal: 06902
• Manufacturer Phone: 2033519000
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CONAIR MASSAGER
• Generic Name: HEATED MASSAGER
• Product Code: ISA
• Date Received: 2014-07-29
• Model Number: WM25CS
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONAIR CORP.
• Manufacturer Address: STAMFORD CT US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-07-29