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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODCUTS, LLC. EASY TOUCH INSULIN SYRINGE Back to Search Results
Catalog Number 627155 OR 628155 OR 627555
Device Problems Detachment Of Device Component (1104); Physical Property Issue (3008)
Patient Problems Abscess (1690); Bacterial Infection (1735); Patient Problem/Medical Problem (2688)
Event Date 04/09/2018
Event Type  Injury  
Manufacturer Narrative
It was disclosed to the manufacturer that it is unknown if the device was used for its intended use to admisiter insulin. Mhc has been given minimal information and no specific lot or item number was provided however several lot numbers and item numbers were sighted by the complainant the complaint came from a needle exchange unit. The patient is ananymous and limited informaiton was provided to mhc regarding the incident.
 
Event Description
Needle disengaged from syringe while sill in arm needle was removed abcess later developed and user went to the hospital for treatment and recovered.
 
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Brand NameEASY TOUCH
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODCUTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODCUTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7636572
MDR Text Key112271015
Report Number3005798905-2018-00986
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number627155 OR 628155 OR 627555
Device Lot Number37801, 37803, 41795, 47601
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 Received04/17/2018
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?
Type of Device Usage Unkown

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