FDA Adverse Event
Malfunction
Summary report: N
T4 ZPR TOGA W/INT SHLDR TIES
MDR report key: 7298024
·
Received February 26, 2018
Report
- Report Number
- 0001811755-2018-00454
- Event Type
- Malfunction
- Date Received
- February 26, 2018
- Date of Event
- February 1, 2018
- Report Date
- February 26, 2018
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DISCARDED AT ACCOUNT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY, THERE WAS A TEAR IN THE TOGA AND THE OUTER LAYER OF PLASTIC WAS PEELING OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140846 | T4 ZPR TOGA W/INT SHLDR TIES | SURGICAL, GOWN | FYA | STRYKER INSTRUMENTS-KALAMAZOO | 17092644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |