• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR LLC. CONAIR; 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 LLC. CONAIR; MASSAGER Back to Search Results
Model Number BM1RLF
Device Problem Smoking (1585)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4) - the consumer accepted an replacement product and will not return the original product to the manufacturer for an investigation.
 
Event Description
On (b)(6) 2022 - the consumer claims the controller started to smoke.The consumer accepted a replacement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONAIR
Type of Device
MASSAGER
Manufacturer (Section D)
CONAIR LLC.
1 cummings point rd.
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key14285813
MDR Text Key299587614
Report Number1222304-2022-00013
Device Sequence Number1
Product Code ISA
UDI-Device Identifier74108061072
UDI-Public74108061072
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 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBM1RLF
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/05/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-