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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGES
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGES Back to Search Results
Catalog Number 731365
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
Event Type  malfunction  
Event Description
Product user reports that insulin is leaking out of the syringe from the cannula before use.Due to this, the end user is not receiving their full dosage of insulin.
 
Manufacturer Narrative
Initial trend analysis for lot 56555 was conducted, no malfunctions were found.This is the only complaint for lot 56555.Further investigation will be conducted to determine the root cause of complaint.
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGES
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
Manufacturer Contact
troy smith
8695 seward road
fairfield, OH 45011
MDR Report Key16018869
MDR Text Key307682029
Report Number3005798905-2022-03089
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 Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number731365
Device Lot Number56555
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2022
Initial Date FDA Received12/20/2022
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
Patient Sequence Number1
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