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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 31G-1CC-5/16" SYRINGE, PISTON

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MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 31G-1CC-5/16" SYRINGE, PISTON Back to Search Results
Model Number 831165
Device Problems Bent (1059); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2017
Event Type  malfunction  
Event Description
User allegedly received bent needles in three boxes of product.
 
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Brand NameEASYTOUCH INSULIN SYRINGE 31G-1CC-5/16"
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7606708
MDR Text Key111232183
Report Number3005798905-2018-02240
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number831165
Device Lot Number43986A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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