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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 731565
Device Problems Fluid Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2019
Event Type  malfunction  
Event Description
Insulin leaking where the needle meets the barrel.
 
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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 Key9242384
MDR Text Key163956152
Report Number3005798905-2019-02866
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 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number731565
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2019
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

Patient Treatment Data
Date Received: 10/25/2019 Patient Sequence Number: 1
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