FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P - US HALF DOSE 10-PK
MDR report key: 2091022
·
Received May 12, 2011
Report
- Report Number
- 9610726-2011-00154
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- N17004
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CEMENT RECEIVED BY HOSPITAL ON (B)(6) 2011. PACKAGING COMPLETELY SOAKED. WE ARE NOT NOTIFIED UNTIL (B)(6) 2011. CATALOG NUMBER 6188-010 AND LOT CODE RAS015."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P - US HALF DOSE 10-PK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | RAS015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |