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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. MEMBER'S MARK INSULIN SYRINGE

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MHC MEDICAL PRODUCTS, LLC. MEMBER'S MARK INSULIN SYRINGE Back to Search Results
Catalog Number 731365
Device Problems Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2019
Event Type  malfunction  
Event Description
Syringe is releasing insulin before the user is ready to inject.
 
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Brand NameMEMBER'S MARK
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 Key9242376
MDR Text Key163957054
Report Number3005798905-2019-02855
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102178
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 09/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number731365
Device Lot Number45354
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2019
Was Device Evaluated by Manufacturer? No
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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