FDA Adverse Event
Injury
Summary report: N
ULTRATHANE COOK - COPE TYPE LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
MDR report key: 3760944
·
Received April 9, 2014
Report
- Report Number
- 1820334-2014-00152
- Event Type
- Injury
- Date Received
- April 9, 2014
- Date of Event
- February 27, 2014
- Report Date
- March 14, 2014
- Manufacturer
- COOK INC
- Product Code
- GBO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT WITH INVASIVE UROTHELIAL CARCINOMA (T2 TCC BLADDER CARCINOMA) UNDERWENT ONGOING USE OF DRAINAGE CATHETER (LEFT NEPHROSTOMY DRAINAGE CATHETER CAME APART AT CONNECTION BETWEEN CATHETER AND LUER HUB RESULTING IN PATIENT RETURNING TO HOSPITAL'S EMERGENCY DEPARTMENT SO THE DEVICE COULD BE CHANGED. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE TO REPLACE THE DEVICE THE NEXT DAY ((B)(6) 2014) AND REQUIRED 2 DAYS STAY AS INPATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213286 | ULTRATHANE COOK - COPE TYPE LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | GBO CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERY | GBO | COOK INC | NA | 3988055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |