FDA Adverse Event
Injury
Summary report: N
G2 FILTER SYSTEM - FILTER
MDR report key: 2150713
·
Received June 24, 2011
Report
- Report Number
- 2020394-2011-00146
- Event Type
- Injury
- Date Received
- June 24, 2011
- Report Date
- June 2, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K073090
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ON AN UNKNOWN DATE AFTER FILTER IMPLANT, THE FILTER FRACTURED AND PERFORATED THE CAVA WALL. REPORTEDLY, A FILTER FRAGMENT PENETRATED THE DUODENUM. THE FILTER AND DETACHMENTS WERE SURGICALLY REMOVED. REPORTEDLY, THE PATIENT DEVELOPED A POST OPERATIVE WOUND INFECTION THAT REQUIRED IV ANTIBIOTICS. INFORMATION ON THE CURRENT PATIENT CONDITION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | G2 FILTER SYSTEM - FILTER | DTK | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |