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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 Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2022
Event Type  malfunction  
Event Description
According to the reporter, the device did not sound as programmed or as specified by the manufacturer.  it did not work as indicated in the manual or it was blocked. It was reported that the thermal mattress was alarming without having been previously programmed, and so the temperature sensor was adjusted. There was no reported patient involvement and outcome.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14074609
MDR Text Key289105953
Report Number2936999-2022-00281
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K123083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2022
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? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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