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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEMPTIME CORP. TRANSTRACKER F (HEAT) INDICATOR, PHYSICAL/CHEMICAL

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TEMPTIME CORP. TRANSTRACKER F (HEAT) INDICATOR, PHYSICAL/CHEMICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missed Dose (2561)
Event Date 04/09/2018
Event Type  Injury  
Event Description

Missed dose - pt forgot to order.

 
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Brand NameTRANSTRACKER F (HEAT)
Type of DeviceINDICATOR, PHYSICAL/CHEMICAL
Manufacturer (Section D)
TEMPTIME CORP.
MDR Report Key7421136
MDR Text Key105294686
Report NumberMW5076424
Device Sequence Number1
Product Code OCI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 04/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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