FDA Adverse Event
Malfunction
Summary report: N
SERIES 20000 LEGACY
MDR report key: 3102346
·
Received April 30, 2013
Report
- Report Number
- 2028159-2013-00822
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 3, 2013
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT THERE WAS LEAKAGE FROM THE DRAIN BAG PRIOR TO SURGERY. THE PRODUCT WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INVOLVED AND THERE WAS NO REPORTED HARM TO THE STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188221 | SERIES 20000 LEGACY | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MAXVAC TIPLESS PAK ALJ |