Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE Back to Search Results
Catalog Number 830165
Device Problem Product Quality Problem (1506)
Patient Problem Pain (1994)
Event Date 08/17/2020
Event Type  malfunction  
Event Description
End-user rached out regarding issues with "painful" syringes.The end-user stataed every bag of 30 gauge 8mm syringes are sharp in a sense of painful verses smooth transition into the epidermis.These as of late are horrible and painful." product has been replaced and requested for return for inspection and testing.
 
Event Description
End-user reached out regarding issues with "painful" syringes.The end-user stated every bag of 30 gauge 8mm syringes are sharp in a sense of painful verses smooth transition into the epidermis.These as of late are horrible and painful." product has been replaced and requested for return for inspection and testing.
 
Manufacturer Narrative
Product was not returned by end-user for testing.Trend analysis was conducted to determine if there were identifiable complaint trends.No trend was identified.Production records were analyzed to determine if there was an identifiable abnormalities during production.No malfunctions or abnormalities were identified.Needle sharpness and strength meet standards.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EASYTOUCH
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
MDR Report Key10550743
MDR Text Key207519610
Report Number3005798905-2020-02964
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number830165
Device Lot Number51523A, 51182
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-