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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANMINA SCI CORPORATION WARMTOUCH SYSTEM, THERMAL REGULATING

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SANMINA SCI CORPORATION WARMTOUCH SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5016000
Device Problem Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 01/21/2022
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 unit was overheating. There was no reported patient involvement and outcome.
 
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Brand NameWARMTOUCH
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SANMINA SCI CORPORATION
2700 n 1st st
san jose CA 95134 2015
Manufacturer (Section G)
SANMINA SCI CORPORATION
2700 n 1st st
san jose CA 95134 2015
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key13666940
MDR Text Key286652360
Report Number2936999-2022-00181
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 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2022
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 Manufacturer01/27/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
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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