FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SIL 3WAY 30CC 20FR FOLEY
MDR report key: 2191534
·
Received July 20, 2011
Report
- Report Number
- 8040412-2011-00106
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Report Date
- July 6, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- EZL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: PER (B)(4) AFFILIATE: THE BALLOON DEFLATED AND THE CATHETER SLIPPED OUT OF THE PT AT THE 2ND POSTOPERATIVE DAY. NO PT INJURY REPORTED PT CURRENT CONDITION IS FINE. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH 100% SIL 3WAY 30CC 20FR FOLEY | FOLEY CATHETER | EZL | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |