PILL CRUSHER 921-6439-0000 10/10 640-6439-0000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-19 for PILL CRUSHER 921-6439-0000 10/10 640-6439-0000 manufactured by Briggs Medical Service Company.

Event Text Entries

[5876227] During the twisting/crushing of the pill (norvasc) the bottom of crusher broke contaminating the medication. The pill and a portion of the upper level of the pill crusher fell into bottom portion of the pill compartment. ======================manufacturer response for pill crusher, (brand not provided) (per site reporter). ======================i talked to customer service (b)(4). Sent her an email stating the details of the incident and asked to start the process for returning the pill crusher for investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4790488
MDR Report Key4790488
Date Received2015-05-19
Date of Report2015-05-19
Date of Event2015-05-15
Report Date2015-05-19
Date Reported to FDA2015-05-19
Date Reported to Mfgr2015-05-22
Date Added to Maude2015-05-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePILL CRUSHER
Generic NamePILL CRUSHER/CUTTER
Product CodeKME
Date Received2015-05-19
Model Number921-6439-0000 10/10
Catalog Number640-6439-0000
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age3 DA
Device Sequence No1
Device Event Key0
ManufacturerBRIGGS MEDICAL SERVICE COMPANY
Manufacturer Address7887 UNIVERSITY BLVD. DES MOINES IA 50306 US 50306


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-19

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