FDA Adverse Event
Injury
Summary report: N
MINIMED QUICK-SET
MDR report key: 19509957
·
Received June 11, 2024
Report
- Report Number
- 3003442380-2024-07710
- Event Type
- Injury
- Date Received
- June 11, 2024
- Date of Event
- May 10, 2024
- Report Date
- June 11, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1884752 - DEVICE 1 OF 2. PATIENT COUNTRY: BAHRAIN. PATIENT CITY: (B)(6).
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BAHRAIN. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SETS WAS FELL OFF DURING USE EVENT ON 10-MAY-2024. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1089875 | MINIMED QUICK-SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-397A | 6003390 | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |