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