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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) WARMTOUCH SYSTEM, THERMAL REGULATING

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MMJ SA DE CV (USD) WARMTOUCH SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5016000
Device Problems Insufficient Heating (1287); Mechanical Problem (1384); Ambient Noise Problem (2877)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device had heating problem, after a while it stopped working, had an error and super noisy. There was no reported patient involvement and outcome.
 
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Brand NameWARMTOUCH
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX 32590
Manufacturer (Section G)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX 32590
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key13657482
MDR Text Key286652710
Report Number2936999-2022-00177
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier10884521141100
UDI-Public10884521141100
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K123083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5016000
Device Catalogue Number5016000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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