FDA Adverse Event
Malfunction
Summary report: N
SMARTSET GHV GENTAMICIN 40G
MDR report key: 1973488
·
Received January 12, 2011
Report
- Report Number
- 1818910-2011-00480
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- PMA / PMN Number
- K033563
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
DEPUY CEMENT WAS OPENED, NON STERILE INNER POUCH WAS PUT INTO STERILE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSET GHV GENTAMICIN 40G | 87 LOD, MBB | LOD | DEPUY CMW | NA | 3134744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |