CARTRIDGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for CARTRIDGE manufactured by Unk.

Event Text Entries

[91205087] Pt stated that cartridge malfunctioned and pt was not able to give dosage. Prescriber and mfr are aware. Pt will continue on medication. Dose or amount: 100mcg, frequency: daily, route: subcutaneously. Dates of use: from (b)(6) 2016 to ongoing. Diagnosis or reason for use: hypoparathyroidism. Reported to (b)(6) by: pt/caregiver. Physician name: (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073151
MDR Report Key7002947
Date Received2017-11-06
Date of Report2017-10-31
Date of Event2017-10-28
Date Added to Maude2017-11-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCARTRIDGE
Generic NameSYRINGE, CARTRIDGE
Product CodeEJI
Date Received2017-11-06
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-06

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