FDA Adverse Event
Other
Summary report: N
CURITY ULTRAMER CATHETER
MDR report key: 277869
·
Received May 11, 2000
Report
- Report Number
- 9611712-2000-00001
- Event Type
- Other
- Date Received
- May 11, 2000
- Date of Event
- April 5, 2000
- Report Date
- May 11, 2000
- Manufacturer
- THE KENDALL CO
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 4/5/2000 AT HOSP WHEN THE 1616 FOLEY CATHETER WAS REMOVED FROM THE PT, THE LATEX BALLOON WAS MISSING. DR HAD TO RETRIEVE BALLOON FROM PT. NO PERMANENT INJURY RESULTED. KENDALL'S QUALITY ASSURANCE DEPT WAS NOTIFIED OF THIS EVENT ON 4/12/2000.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURITY ULTRAMER CATHETER | 16 FRENCH FOLEY CATHETER | KOD | THE KENDALL CO | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |