FDA Adverse Event
Malfunction
Summary report: N
CUSTOM PAK
MDR report key: 3221282
·
Received June 13, 2013
Report
- Report Number
- 2028159-2013-01133
- Event Type
- Malfunction
- Date Received
- June 13, 2013
- Date of Event
- May 16, 2013
- Report Date
- May 17, 2013
- Manufacturer
- ALCON MANUFACTURING, LTD.
- Product Code
- KYG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY, THE SURGEON WAS ABLE TO PUT THE TROCAR IN BUT THE PLUG IS TOO WIDE IN THE MIDDLE AND POPS BACK OUT. THERE WAS NO DELAY OR PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267920 | CUSTOM PAK | CONVENIENCE KIT | KYG | ALCON MANUFACTURING, LTD. | CUSTOM PAK | 13014516X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25+ TOTAL PLUS PAK |