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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
Catalog Number 930155
Device Problems Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
Event Type  malfunction  
Event Description
Initial call was (b)(4) 2018. When asking for information, customer was unsure of the item and lot #'s. She stated she was going to take pictures and email the information to me. Email of pics were received; (b)(6) along with the detailed email provided in the complaint field. Due to not being able to ship to a po box, a request of her physical address was made. I received an email of her complete address (b)(4) 2018. Based on the information provided, there are 2 different lot's provided on this complaint. Customer wasn't sure which lot # ; pictured syringes were from.
 
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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
MDR Report Key7712529
MDR Text Key114802158
Report Number3005798905-2018-00716
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 07/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number930155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
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? No
Type of Device Usage Initial

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