FDA Adverse Event
Other
Summary report: N
PERCLOSE
MDR report key: 472861
·
Received July 22, 2003
Report
- Report Number
- 472861
- Event Type
- Other
- Date Received
- July 22, 2003
- Date of Event
- July 7, 2003
- Report Date
- July 9, 2003
- Manufacturer
- PERCLOSE INC
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 09/05/03: THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED. 12337. THE MANUFACTURING LOT. 050626H. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AND INVESTIGATION AS IT HAS BEEN SEQUESTERED BY THE FACILITY. MFR WAS NOT ABLE TO ESTABLISH A ROOT CAUSE BASED ON THE AVAILABLE INFO. THE DATE THAT MFR RECEIVED INFO ABOUT THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT: 07/14/2003.
Description of Event or Problem · 1
PT WAS CATHED AND A 6FR PERCLOSE WAS USED TO CLOSE VESSEL. PT READMITTED WITH AN INFECTION IN RIGHT GROIN 8 DAYS LATER. RIGHT GROIN SUBCUTANEOUS ABSCESS AND BACTEREMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCLOSE | VASCULAR CLOSURE DEVICE | MGB | PERCLOSE INC | 12337 | 050626H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |