MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; PEN NEEDLE

Model Number NOT PROVIDED

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Blood Loss (2597)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

Bruising and bleeding after use.

• Brand Name: EASY TOUCH
• Type of Device: PEN NEEDLE
• 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 ; 8773584342
• MDR Report Key: 7361846
• MDR Text Key: 103528363
• Report Number: 3005798905-2018-00002
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: 832041
• Device Lot Number: P14556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• 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