SYMPHONY 673405

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SYMPHONY 673405 manufactured by Medela Llc.

Event Text Entries

[177370402] Poor suction and condensation in tubing while pumping breast milk. Loose valve, replaced pump.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9659283
MDR Report Key9659283
Date Received2020-02-03
Date of Report2019-12-30
Date of Event2019-12-12
Report Date2019-12-30
Date Reported to FDA2019-12-30
Date Reported to Mfgr2020-02-03
Date Added to Maude2020-02-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYMPHONY
Generic NameBREAST PUMP KIT
Product CodeHGX
Date Received2020-02-03
Returned To Mfg2019-12-12
Catalog Number673405
Lot Number456380
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDELA LLC
Manufacturer Address1101 CORPORATE DR. MCHENRY IL 60050 US 60050


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

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