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

Catalog Number 831165

Device Problem Dull, Blunt (2407)

Patient Problem Pain (1994)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

End-user called in reporting that the syringes manufactured in (b)(4) are more painful than the syringes manufactured in (b)(4).

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, oh
• MDR Report Key: 10305286
• MDR Text Key: 199864418
• Report Number: 3005798905-2020-02960
• 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
• Remedial Action: Replace
• Type of Report: Initial
• 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: 831165
• Device Lot Number: 51145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/21/2020
• 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