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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODUCTS, LLC EASYTOUCH SYRINGE Back to Search Results
Catalog Number 828155
Device Problems Shipping Damage or Problem (1570); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Abscess (1690); Skin Inflammation/ Irritation (4545)
Event Date 03/08/2021
Event Type  malfunction  
Manufacturer Narrative
When initial trend analysis for lot numbers 52215 and 52211 was concluded this was the only complaint received. Further investigation will be conducted for root cause of complaint.
 
Event Description
End user reports that syringes are dull and bent. However, customer suggests that the product is not being used for its intended purpose. Syringe lot numbers 52215 expiration date 07/20/2025 and 52211 expiration date 07/16/2025.
 
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Brand NameEASYTOUCH
Type of DeviceSYRINGE
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 Key11641974
MDR Text Key245925057
Report Number3005798905-2021-02997
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,Followup,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number828155
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
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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