FDA Adverse Event
Malfunction
Summary report: N
T4 ZIPPER TOGA, L/XL
MDR report key: 7263612
·
Received February 12, 2018
Report
- Report Number
- 0001811755-2018-00408
- Event Type
- Malfunction
- Date Received
- February 12, 2018
- Date of Event
- January 10, 2018
- Report Date
- February 12, 2018
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYA
- UDI-DI
- 4546540152688
- PMA / PMN Number
- K070078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DISCARDED AT ACCOUNT
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE MATERIAL OF THE TOGA WAS TEARING. 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 |
|---|---|---|---|---|---|---|---|
| 108174 | T4 ZIPPER TOGA, L/XL | GOWN, SURGICAL | FYA | STRYKER INSTRUMENTS-KALAMAZOO | 17082333 | 4546540152688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |