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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 30G-.5CC-5/16"; SYRINGE, PISTON
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 30G-.5CC-5/16"; SYRINGE, PISTON Back to Search Results
Model Number 830565
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2018
Event Type  malfunction  
Event Description
User alleged that the syringes were hard to pull back when filling the syringes and would have to push harder when inserting the insulin into her pet.The first 2 packs worked properly, however when getting to the 3rd or 4th pack of syringes was when the trouble started.
 
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Brand Name
EASYTOUCH INSULIN SYRINGE 30G-.5CC-5/16"
Type of Device
SYRINGE, 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 Key7607764
MDR Text Key111308874
Report Number3005798905-2018-02295
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
1 Patient was 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 Lay User/Patient
Device Model Number830565
Device Lot Number44434B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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