FDA Adverse Event
Injury
Summary report: N
EASY CORE BIOPSY DEVICE
MDR report key: 1522946
·
Received November 5, 2009
Report
- Report Number
- 3005099803-2009-05237
- Event Type
- Injury
- Date Received
- November 5, 2009
- Report Date
- October 12, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FCG
- PMA / PMN Number
- K050120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL NUMBER OR LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNK.
Description of Event or Problem · 1
ON OCTOBER 12, 2009, A BOSTON SCIENTIFIC CORP EMPLOYEE BECAME AWARE OF AN ARTICLE, "OUTPATIENT PERCUTANEOUS RENAL BIOPSY IN ADULT PATIENTS" BY ABDULLA K. AL-KWEISH, ET.AL. PUBLISHED IN FOREIGN JOURNAL OF KIDNEY DISEASES AND TRANSPLANTATION 2007; 18 (4): 541-546. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: AN EASY CORE BIOPSY DEVICE WAS USED DURING A PERCUTANEOUS RENAL BIOPSY OF THE KIDNEY. ACCORDING TO THE ARTICLE, GROSS TRANSIENT HEMATURIA WAS OBSERVED WITHIN SIX HOURS POST PROCEDURE. ATTEMPTS HAVE BEEN UNSUCCESSFUL TO OBTAIN ADD'L INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASY CORE BIOPSY DEVICE | FCG | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |