FDA Adverse Event
Malfunction
Summary report: N
11.5FR X 13.5CM MAHURKAR KIT
MDR report key: 4143631
·
Received October 6, 2014
Report
- Report Number
- 1317749-2014-00135
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- February 5, 2014
- Report Date
- December 2, 2024
- Manufacturer
- COVIDIEN
- Product Code
- FOZ
- PMA / PMN Number
- K192302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626329 | 11.5FR X 13.5CM MAHURKAR KIT | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COVIDIEN | 8813817005 | 028821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |