• 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 EASY TOUCH INSLUIN 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 EASY TOUCH INSLUIN SYRINGE Back to Search Results
Model Number NOT PROVIDED
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/12/2017
Event Type  Injury  
Event Description
Needle broke off in abdomen-used a new syringe, customer said she did everything routine but when she pulled back, she noticed it wasn't attached to the syringe went to er and got a ctc, confirming the needle is stuck in her abdomen and needing surgery to remove needle.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEASY TOUCH
Type of DeviceINSLUIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
8773584342
MDR Report Key7366520
MDR Text Key103334449
Report Number3005798905-2018-00009
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOT PROVIDED
Device Catalogue Number831565
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/12/2017
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

Patient Treatment Data
Date Received: 03/23/2018 Patient Sequence Number: 1
-
-