Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION BMS3WT - MASSAGER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONAIR CORPORATION BMS3WT - MASSAGER Back to Search Results
Model Number BMS3WT
Device Problem Insufficient Information (3190)
Patient Problems Anxiety (2328); Depression (2361); Partial thickness (Second Degree) Burn (2694)
Event Date 10/05/2015
Event Type  Injury  
Manufacturer Narrative
The device is no longer sold and has not been supplied in the us for approximately 15 years.Within the past 20 years, this is the second alleged malfunction received for this product.Device not submitted to manufacturer.
 
Event Description
Consumer alleges to have received 2nd degree burns from laying on the massager for her back, but she received the burn on her left hip back area.She claims to have received medical attention and that the er has given her pain medications and creams.She claims to have severe depression and anxiety from this incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BMS3WT - 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 Key5180092
MDR Text Key29323571
Report Number1222304-2015-00022
Device Sequence Number1
Product Code ISA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 10/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberBMS3WT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/08/2015
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 Number1
Patient Outcome(s) Other;
Patient Age45 YR
-
-