FDA Adverse Event
Malfunction
Summary report: N
T4 PULLOVER TOGA, XL
MDR report key: 7169351
·
Received January 5, 2018
Report
- Report Number
- 0001811755-2018-00018
- Event Type
- Malfunction
- Date Received
- January 5, 2018
- Date of Event
- December 7, 2017
- Report Date
- January 5, 2018
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYA
- UDI-DI
- 4546540904232
- PMA / PMN Number
- K070078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED BECAUSE IT WAS A BIOHAZARD (COVERED IN BLOOD).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DONNING OF A SURGICAL PROCEDURE AT THE USER FACILITY, THE TOGA MATERIAL FELT THIN AND RIPPED. 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 |
|---|---|---|---|---|---|---|---|
| 13108 | T4 PULLOVER TOGA, XL | GOWN, SURGICAL | FYA | STRYKER INSTRUMENTS-KALAMAZOO | 17061775 | 4546540904232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |