FDA Adverse Event
Other
Summary report: N
SIGNIA
MDR report key: 17735381
·
Received September 13, 2023
Report
- Report Number
- 17735381
- Event Type
- Other
- Date Received
- September 13, 2023
- Date of Event
- July 27, 2023
- Report Date
- August 1, 2023
- Manufacturer
- COVIDIEN LP
- Product Code
- GDW
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
2 SIGNIA HANDLES AND 2 SIGNIA XL ADAPTOR MALFUNCTIONED. THE 4 ITEMS WERE SEQUESTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2059831 | SIGNIA | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16060 DA | Unknown |