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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.
 
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.
 
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 conducted further investigation regarding the shipper of the product and possible mold contamination.No abnormalities were found at time of production.
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
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
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/09/2021
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 Number822331
Device Lot Number53808
Initial Date Manufacturer Received 06/03/2021
Initial Date FDA Received06/11/2021
Supplement Dates Manufacturer Received06/03/2021
Supplement Dates FDA Received07/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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