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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASYTOUCH INSULIN SYRINGE

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MHC MEDICAL PRODUCTS, LLC. EASYTOUCH INSULIN SYRINGE Back to Search Results
Catalog Number 830365
Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2019
Event Type  malfunction  
Event Description
Incorrect syringe size found in box.
 
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Brand NameEASYTOUCH
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
8695 seward rd.
fairfield OH 45011
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
8695 seward rd.
fairfield OH 45011
Manufacturer Contact
jennifer seiple
8695 seward road
fairfield, OH 45011
MDR Report Key9093639
MDR Text Key163956510
Report Number3005798905-2019-02869
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number830365
Device Lot Number47783C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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