FDA Adverse Event
Malfunction
Summary report: N
STELLARIS OPTIMIZED STABILITY VACUUM PACK
MDR report key: 2153435
·
Received June 21, 2011
Report
- Report Number
- 1920664-2011-00068
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 20, 2011
- Report Date
- May 23, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQC
- PMA / PMN Number
- K063331
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
REPORT RECEIVED FROM FRANCE STATES: "SEPARATION OF PNEUMATIC TUBING DURING SURGERY. NO PATIENT IMPACT." ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLARIS OPTIMIZED STABILITY VACUUM PACK | HQC | BAUSCH & LOMB | U4851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STELLARIS EQUIPMENT (BAUSCH + LOMB) |