FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 14269573
·
Received May 3, 2022
Report
- Report Number
- 3005798905-2022-03057
- Event Type
- Malfunction
- Date Received
- May 3, 2022
- Date of Event
- April 29, 2022
- Report Date
- April 29, 2022
- Manufacturer
- MHC MEDICAL PRODUCTS, LLC
- Product Code
- FMI
- PMA / PMN Number
- K112789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RETAINED LOT 523919 WAS INVESTIGATED FOR TORQUE WITH VARIOUS INSULIN PENS AND NO MALFUNCTION WAS FOUND.
Description of Event or Problem · 0
END USER REPORTS THAT WHILE USING LOT NUMBER 523919 PEN NEEDLES ARE DIFFICULT TO TWIST ON AND OFF THE HUMALOG INSULIN PEN. REFERENCE THE REPORT (B)(4), WHERE END USER REPORTED SAME COMPLAINT BUT ALSO REPORTED THE CANNULA IS PAINFUL WHEN INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318868 | EASYTOUCH | PEN NEEDLE | FMI | MHC MEDICAL PRODUCTS, LLC | 523919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |