FDA Adverse Event
Malfunction
Summary report: N
SUPER FUNNEL CARTRIDGE
MDR report key: 720406
·
Received July 22, 2005
Report
- Report Number
- 2023826-2005-00990
- Event Type
- Malfunction
- Date Received
- July 22, 2005
- Date of Event
- June 22, 2005
- Report Date
- June 23, 2005
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MSS
- PMA / PMN Number
- na
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE SFC-25 PP CARTRIDGE WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER FUNNEL CARTRIDGE | IOL INJECTION CARTRIDGE | MSS | STAAR SURGICAL COMPANY | SFC-25 FP | 1195417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |