FDA Adverse Event
Death
Summary report: N
VACU-AIDE
MDR report key: 14427
·
Received January 10, 1994
Report
- Report Number
- 2515872-1993-00002
- Event Type
- Death
- Date Received
- January 10, 1994
- Date of Event
- November 11, 1991
- Report Date
- November 3, 1993
- Manufacturer
- DEVILBISS HEALTH CARE, INC.
- Product Code
- MCJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE USER OF THE VACU-AIDE DIED OF CARDIOPULMONARY ARREST. HE SUFFERED FROM BIRTH WITH SPINA BIFIDA AND ARNOLD CHIARI SYNDROME. NOTICE WAS RECEIVED OF THE DEATH ON 10/29/93 AND AN INVESTIGATION IS ONGOING OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VACU-AIDE | MCJ | DEVILBISS HEALTH CARE, INC. | 7304D | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Death |