FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 17165939
·
Received June 20, 2023
Report
- Report Number
- 3005798905-2023-03121
- Event Type
- Malfunction
- Date Received
- June 20, 2023
- Date of Event
- June 8, 2023
- Report Date
- June 20, 2023
- Manufacturer
- FEEL TECH BIO CO., LTD.
- 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
THE AFFECTED DEVICE WAS RETURNED TO THE CMO ON (B)(6) 2023 TESTING, DURING DEVICE TESTING THE CMO FOUND NO IRREGULARITIES AND THE DEVICE WAS FOUND TO BE IN GOOD WORKING CONDITION. COMPLAINT CLOSED PER CMO BASED ON RESULTS FROM TESTING.
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 568718P WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 568718P. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Description of Event or Problem · 0
END USER REPORTS THAT EASYTOUCH PEN NEEDLES ITEM NUMBER 831041 LOT 568718P ARE DULL.
Description of Event or Problem · 0
END USER REPORTS THAT EASYTOUCH PEN NEEDLES ITEM NUMBER 831041 LOT 568718P ARE DULL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526566 | EASYTOUCH | PEN NEEDLE | FMI | FEEL TECH BIO CO., LTD. | 568718P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |