FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 1791400
·
Received August 6, 2010
Report
- Report Number
- 3002037047-2010-00129
- Event Type
- Malfunction
- Date Received
- August 6, 2010
- Report Date
- July 8, 2010
- Manufacturer
- ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 (B)(4) WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4) .
Description of Event or Problem · 1
ADVERSE EVENT(S): ¿NO IMPACT WAS REPORTED¿ (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): ¿BLUE FLUFFS IN THE EYE¿ (FOREIGN MATERIAL PRESENT IN DEVICE). THE CUSTOMER (SURGEON) REPORTED: BLUE FLUFFS GOT INTO PATIENT¿S EYES. THE FLUFFS WERE REMOVED DURING THE PROCEDURE. NO IMPACT WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V. | CUSTOM PAK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |