MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; INSULIN SYRINGE

Catalog Number 831165

Device Problems Bent (1059); Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 04/09/2018

Event Type  malfunction  

Event Description

Calling on behalf of his wife.When inserting the needle into her stomach, the needle bend.Also, when inserting into the insulin rubber it also bends.

Event Description

Calling on behalf of his wife.When inserting the needle into her stomach, the needle bend.Also, when inserting into the insulin rubber it also bends.

• Brand Name: EASY TOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati, oh OH 45240
• MDR Report Key: 7501015
• MDR Text Key: 107825324
• Report Number: 3005798905-2018-00499
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K091474
• 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: 05/09/2018

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: Patient Family Member or Friend
• Device Catalogue Number: 831165
• Device Lot Number: 831165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 02/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other