FDA Adverse Event
Other
Summary report: N
RIGID TIP CHOLANGIOGRAPHY CATHETER
MDR report key: 1694431
·
Received May 11, 2010
Report
- Report Number
- 2027111-2010-00062
- Event Type
- Other
- Date Received
- May 11, 2010
- Date of Event
- April 22, 2010
- Report Date
- May 11, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GBZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
STERILE PRODUCT FROM SAME LOT NUMBER IS ANTICIPATED TO BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE ISSUED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
"TWO SEPARATE INCIDENTS UNDER THIS CER SURGEON EXPERIENCED DIFFICULTY IN INTRODUCING THE CATHETER SHEATH IN THE CANNULA. ONE OF THE INCIDENTS REQUIRED A RECOVERY REINTERVENTION. NONE OF THE INCRIMINATED PRODUCTS ARE RETURNED BUT CUSTOMER WANTS TO RETURN THE CATHETERS OF THAT SAME BATCH NUMBER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGID TIP CHOLANGIOGRAPHY CATHETER | CHOLANGIOGRAPHY CATHETER | GBZ | APPLIED MEDICAL RESOURCES | C1002 | 1105748 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |