FDA Adverse Event
Injury
Summary report: N
NAVILYST MEDICAL/ EXODUS
MDR report key: 3143139
·
Received May 30, 2013
Report
- Report Number
- 1317056-2013-00022
- Event Type
- Injury
- Date Received
- May 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- NAVILYST MEDICAL
- Product Code
- LJE
- PMA / PMN Number
- K111315
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE FROM THE REPORTED EVENT HAS BEEN RETURNED TO NAVILYST MEDICAL. AS THIS IS A PURCHASED ITEM, THE SAMPLE IS NOW BEING FORWARDED TO OUR SUPPLIER, MEDVENTURE, ALONG WITH A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).
Description of Event or Problem · 1
AS REPORTED, NEPHROSTOMY DRAINAGE CATHETER "DISINTEGRATED" INSIDE THE PATIENT. IT WAS REMOVED BY A PHYSICIAN AND "ABOUT 95%" OF THE DEVICE WAS RETURNED FOR EVALUATION. NAVILYST MEDICAL IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THIS EVENT, INCLUDING THE LENGTH OF TIME THE CATHETER WAS IMPLANTED, THE LOCATION OF THE PLACEMENT, AND THE CURRENT PATIENT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240037 | NAVILYST MEDICAL/ EXODUS | NEPHROSTOMY DRAINAGE CATHETER | LJE | NAVILYST MEDICAL | NA | ML00000571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |