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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 822331
Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
During initial trend analysis for lot number 53808, no other complaints were located for both the product nor the packaging of the product. Mhc will be conducting further investigation regarding the shipper of the product and possible mold contamination. No abnormalities were found at time of production.
 
Event Description
Mhc received documentation from a customer that a shipment delivered appeared to have mold contamination on the outside of the wrapped product boxes. The product is being returned back to mhc for further inspection of the possible contamination. Mhc is also doing their due diligence on the shipper based on how the product was shipped to the customer.
 
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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 Key11984891
MDR Text Key255721389
Report Number3005798905-2021-03009
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 distributor
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number822331
Device Lot Number53808
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 Received06/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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