FDA Adverse Event
Malfunction
Summary report: N
EASYTOUCH
MDR report key: 17260421
·
Received July 5, 2023
Report
- Report Number
- 3005798905-2023-03127
- Event Type
- Malfunction
- Date Received
- July 5, 2023
- Date of Event
- June 30, 2023
- Report Date
- July 5, 2023
- 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
THE AFFECTED DEVICE WAS RETURNED TO THE CMO ON 08-02-2023 TESTING, DURING DEVICE TESTING THE CMO FOUND NO IRREGULARITIES AND THE DEVICE WAS FOUND TO BE IN GOOD WORKING CONDITION.
Additional Manufacturer Narrative · 0
PRODUCTION RECORDS INVESTIGATED FOR LOT NUMBER 59932C. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.
Description of Event or Problem · 0
USER REPORTS COMPLETE BLOCKAGE WHILE DRAWING IN MEDICATION WITH SYRINGES ITEM 831365, LOT NUMBER 59932C.
Description of Event or Problem · 0
USER REPORTS COMPLETE BLOCKAGE WHILE DRAWING IN MEDICATION WITH SYRINGES ITEM 831365 LOT NUMBER 59932C.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460620 | EASYTOUCH | SYRINGES | FMF | FEEL TECH BIO CO., LTD. | 59932C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |