FDA Adverse Event Summary report: N

CADD PRIZM

MDR report key: 1865108 · Received October 1, 2010

Report

Report Number
1865108
Date Received
October 1, 2010
Date of Event
July 15, 2010
Report Date
October 1, 2010
Manufacturer
SMITHS MEDICAL ASD INC.
Product Code
MEA
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE RESERVOIR VOLUME INCREASED FROM MORNING INSTEAD OF DECREASING. THE PATIENT REMAINED PAIN FREE, BUT IT DID NOT APPEAR THAT ANY OF THE PAIN MEDICATION IN THE PCA PUMP HAD INFUSED.======================HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CADD PRIZM PCA PUMP MEA SMITHS MEDICAL ASD INC. 6100 NA

Patients

Seq Age Sex Outcome Treatment
1 29 YR