FDA Adverse Event
Malfunction
Summary report: N
DOMESTIC DUEL PK VERTAPLEX
MDR report key: 2241652
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03220
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- NDN
- PMA / PMN Number
- K072118
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE DONE WHEN THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
UPON OPENING THE PACKAGE, IT WAS NOTICED THAT THE VIAL OF MONOMER HAD BROKEN AND WAS EMITTING AN ODOR. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOMESTIC DUEL PK VERTAPLEX | NDN | STRYKER INSTRUMENTS KALAMAZOO | VJR017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |