FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 18619376
·
Received January 31, 2024
Report
- Report Number
- 3005798905-2024-03161
- Event Type
- Malfunction
- Date Received
- January 31, 2024
- Date of Event
- January 25, 2024
- Report Date
- January 31, 2024
- Manufacturer
- FEEL TECH BIO CO., LTD.
- Product Code
- FMF
- PMA / PMN Number
- K102178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CMO INSPECTED RETAINED LOT 60972A, NO ABNORMALITIES WERE FOUND DURING TESTING.
Additional Manufacturer Narrative · 0
INITIAL TREND ANALYSIS FOR LOT 60972A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 60972A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.
Description of Event or Problem · 0
END USER REPORTS THAT WHILE USING SYRINGES WITH LOT 60972A EXP DATE 06/26/2028 IS DULL. USER STATES THE AT TIMES THE RUBBER GASKET WILL BE WHEN ENOUGH FORCE IS APPLIED WHILE INJECTING INSULIN.
Description of Event or Problem · 0
END USER REPORTS THAT WHILE USING SYRINGES WITH LOT 60972A EXP DATE 06/26/2028 IS DULL. USER STATES THE AT TIMES THE RUBBER GASKET WILL BE WHEN ENOUGH FORCE IS APPLIED WHILE INJECTING INSULIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1109475 | EASYTOUCH | SYRINGES | FMF | FEEL TECH BIO CO., LTD. | 60972A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |