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

Catalog Number 628555

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Insufficient information was provided to provide thorough investigation.The reporter made known there was an injury that occurred, however, the reporter was unable further information.A trend analysis of all documented complaints was performed to determine if there was a reoccurring complaint type.No reoccurring complaint type was identified.

Event Description

Reporter sent an email to mhc stating that they received notification that "someonone was injured." the reporting party provided no further information on the injury or the incident that occurred to cause an injury.End-user stated lot # et37803 was being used at the time of the injury.The lot is currently expired and the reporter has been made aware of the lot's expiration.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 11597287
• MDR Text Key: 243206346
• Report Number: 3005798905-2021-02991
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 628555
• Device Lot Number: ET37803
• Date Manufacturer Received: 03/26/2021
• 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: Unknown
• Patient Sequence Number: 1