MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE

Catalog Number 830165

Device Problems Complete Blockage (1094); Dull, Blunt (2407); Obstruction of Flow (2423)

Patient Problem Pain (1994)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

End-user called in to report that they are experiencing insulin syringes that are painful when injecting.There are also a few syringes where they are not able to draw insulin.

Event Description

End-user called in to report that they are experiencing insulin syringes that are painful when injecting.There are also a few syringes where they are not able to draw insulin.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• MDR Report Key: 10305288
• MDR Text Key: 199864454
• Report Number: 3005798905-2020-02961
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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 Number: 830165
• Device Lot Number: 51165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1