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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH INSULIN SYRINGE

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MHC MEDICAL PRODUCTS, LLC EASY TOUCH INSULIN SYRINGE Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem Tissue Damage (2104)
Event Date 05/26/2017
Event Type  malfunction  
Event Description
Half of her box is burred. It rips her skin when she injects herself with insulin.
 
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Brand NameEASY TOUCH
Type of DeviceINSULIN 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 Key7366503
MDR Text Key103532542
Report Number3005798905-2018-00031
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
Remedial Action Replace
Type of Report Initial
Report Date 02/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number828155
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
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 Unkown

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