FDA Adverse Event
Death
Summary report: N
UNK
MDR report key: 445893
·
Received March 3, 2003
Report
- Report Number
- 1216146-2003-00001
- Event Type
- Death
- Date Received
- March 3, 2003
- Date of Event
- September 6, 2002
- Report Date
- February 7, 2003
- Manufacturer
- J. H. EMERSON CO.
- Product Code
- DWM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
A "PUMP" MANUFACTURED BY "EMERSON", UTILIZED IN A SURGICAL PROCEDURE, WAS "DEFECTIVE IN ITS DESIGN AND/OR MANUFACTURE RESULTING IN A CONCURRENT CAUSE OF THE ...INJURY...". THE PROCEDURE REFERRED TO WAS A "VIDEO ASSISTED THORACOSCOPY AND PLEURODESIS...", AFTER WHICH THE PT WENT INTO A CODE BLUE LIFE THREATENING CONDITION...", WHICH EVENTUALLY LED TO THEIR DEATH AFTER "MORE THAN FOUR MONTHS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | UNK | DWM | J. H. EMERSON CO. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| H| L| S |