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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 Device Alarm System (1012); Mechanical Problem (1384); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during servicing, the device failed to alarm.
 
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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 Key13716443
MDR Text Key286918863
Report Number2936999-2022-00200
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K123083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
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 Manufacturer02/22/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received05/11/2022
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 Unkown

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