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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 831565
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
Production records for lot number 52626 were investigated and needle outer diameter showed no indicator of abnormalities or malfunctions.The gradation lines for lot 52626 were also investigated and no malfunctions showed.There were no abnormalities/malfunctions found at time of production.
 
Event Description
End user reports that the circumference of the syringe does not appear to be correct in comparison to another brand.The user also reports that the gradation lines are slanted lightly to the left.
 
Manufacturer Narrative
Production records for lot number 52626 were investigated and needle outer diameter showed no indicator of abnormalities or malfunctions.The gradation lines for lot 52626 were also investigated and no malfunctions showed.There were no abnormalities/malfunctions found at time of production.
 
Event Description
End user reports that the circumference of the syringe does not appear to be correct in comparison to another brand.The user also reports that the gradation lines are slanted lightly to the left.
 
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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 Key11797862
MDR Text Key249716847
Report Number3005798905-2021-03007
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 consumer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/07/2021
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 Number831565
Device Lot Number52626
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received05/10/2021
Supplement Dates Manufacturer Received05/04/2021
Supplement Dates FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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