DELUXE PILL SPLITTER 832314

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-04 for DELUXE PILL SPLITTER 832314 manufactured by Cvs Pharmacy.

Event Text Entries

[16258437] (b)(6) pharmacy has a pill cutter that will jam in the open position. A user attempted to release the jammed mechanism is at serious risk of cutting their finger on the razor blade inside the device. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019331
MDR Report Key1983699
Date Received2011-02-04
Date of Report2011-02-04
Date of Event2011-02-02
Date Added to Maude2011-02-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDELUXE PILL SPLITTER
Generic NamePILL CUTTER
Product CodeOHY
Date Received2011-02-04
Model Number832314
ID NumberUPC 50428 48826
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCVS PHARMACY
Manufacturer AddressWOONSOCKET RI 02895 US 02895


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-02-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.