MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; TEST STRIPS

Catalog Number 807050

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2018

Event Type  malfunction  

Event Description

Defective strips.Receives error.

• Brand Name: EASY TOUCH
• Type of Device: TEST STRIPS
• 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: aryeanne carter ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7720700
• MDR Text Key: 115061387
• Report Number: 3005798905-2018-00729
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 807050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• 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
• Patient Sequence Number: 1