FDA Adverse Event
Other
Summary report: N
PILLING
MDR report key: 306386
·
Received November 7, 2000
Report
- Report Number
- 1055934-2000-00001
- Event Type
- Other
- Date Received
- November 7, 2000
- Date of Event
- August 2, 2000
- Report Date
- August 24, 2000
- Manufacturer
- PILLING SURGICAL
- Product Code
- EWY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MEDIASTINOSCOPE WAS INTRODUCED AND DISSECTION CONTINUED - IT BECAME EVIDENT THAT THERE WAS A TEAR IN THE ANTERIOR ASPECT OF THE TRACHEA AT THE LIMIT OF MEDIASTINOSCOPE REQUIRED THOROCOTOMY TO REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLING | MEDIASTINOSCOPE | EWY | PILLING SURGICAL | 52-2301 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |