FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3960196
·
Received June 24, 2014
Report
- Report Number
- 3002037047-2014-00071
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- January 7, 2014
- Report Date
- May 30, 2014
- Manufacturer
- ALCON - BELGIUM/ ALCON N.V.
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE IS BEING RETURNED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL REPORTED THAT UNKNOWN PARTICLES DESCRIBED AS SMALL FLUFF, SMALL GRAINS, SMALL THREADS WERE NOTICED IN THE CUSTOM PAK DURING THE SURGERY, PARTICLES NOT SELDOMLY FOUND UPON OPENING THE PACKAGING. IT IS UNKNOWN IF THE PARTICLES CAME IN CONTACT WITH THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367395 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - BELGIUM/ ALCON N.V. | CUSTOM PAK | 376352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |