FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3902784
·
Received February 14, 2014
Report
- Report Number
- 1644019-2014-00017
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 14, 2014
- Report Date
- January 16, 2014
- Manufacturer
- ALCON - HOUSTON
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD (DHR) FOR THE LOTS WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE COMPANY'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTED THAT A LEAKAGE OCCURRED FROM THE VALVED TROCAR CANNULA DURING A VITRECTOMY SURGERY. THE PROBLEM WAS SOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98043 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - HOUSTON | CUSTOM PAK | 1490942H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |