FDA Adverse Event
Injury
Summary report: N
FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
MDR report key: 1984443
·
Received February 1, 2011
Report
- Report Number
- 1820334-2011-00057
- Event Type
- Injury
- Date Received
- February 1, 2011
- Report Date
- January 4, 2011
- Manufacturer
- COOK, INC.
- Product Code
- GBX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE UNK AS LOT IS UNK. (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.
Description of Event or Problem · 1
THE HUB SEPARATED AND MIGRATED TO THE PT'S LUNG. THE PT WAS SENT TO THE OPERATING ROOM FOR REMOVAL OF THE SEPARATED SEGMENT. OUTCOME OF THE PT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET | KDQ, BOTTLE, COLLECTION, VACUUM | GBX | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |