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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 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 11/20/2017
Event Type  malfunction  
Event Description
Customer was allegedly having difficulty with the plungers in her syringes.User stated that her pharmacy (optima rx) puts 3 months of syringes in a plastic bag for her so she is without the lot # or exp.Date.Customer service replaced 3 boxes for customer.
 
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Brand Name
EASYTOUCH INSULIN SYRINGE 31G-1CC-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 Key7607762
MDR Text Key111308597
Report Number3005798905-2018-02291
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 Number831165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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