FDA Adverse Event
Malfunction
Summary report: N
T4 HOOD
MDR report key: 6338654
·
Received February 17, 2017
Report
- Report Number
- 0001811755-2017-00617
- Event Type
- Malfunction
- Date Received
- February 17, 2017
- Date of Event
- January 31, 2017
- Report Date
- March 3, 2017
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FYA
- PMA / PMN Number
- FYA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS THE DEVICE WAS NOT RECEIVED IN THE ORIGINAL, STERILE PACKAGING, A ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, FOREIGN MATERIAL WAS FOUND IN THE STERILE PACKAGING OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123114 | T4 HOOD | GOWN, SURGICAL | FYA | STRYKER INSTRUMENTS-KALAMAZOO | 16010094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |