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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; LANCING DEVICE

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MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; LANCING DEVICE Back to Search Results
Catalog Number 808001
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2018
Event Type  malfunction  
Event Description
On (b)(6) 2018, opened new kit and the lancing device is broken.The lancet holder wasn't attached and was broken.
 
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Brand Name
EASY TOUCH
Type of Device
LANCING DEVICE
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
MDR Report Key7774646
MDR Text Key116858539
Report Number3005798905-2018-00785
Device Sequence Number1
Product Code FMK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 07/31/2018
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 Number808001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/13/2018
Initial Date FDA Received08/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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