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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16" SYRINGE, PISTON Back to Search Results
Model Number 831565
Device Problems Bent (1059); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981); Physical Property Issue (3008)
Patient Problem Skin Irritation (2076)
Event Date 02/21/2018
Event Type  malfunction  
Event Description
User allegedly had syringes that were not working appropriately. User described that "when removing the cap, the needle bends and breaks when sticking into the stomach it leaves a bump".
 
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Brand NameEASYTOUCH INSULIN SYRINGE 31G-.5CC-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 Key7606720
MDR Text Key111231187
Report Number3005798905-2018-02247
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
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 Number831565
Device Lot Number44594B & 55027
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? No
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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