GELCLAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for GELCLAIR manufactured by Midatech / Helsinn Healthcare Sa.

Event Text Entries

[181338387] Pt's daughter informed us that the pt passed away.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093306
MDR Report Key9763506
Date Received2020-02-26
Date of Report2020-02-25
Date Added to Maude2020-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameGELCLAIR
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-02-26
Lot Number080811
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMIDATECH / HELSINN HEALTHCARE SA

Device Sequence Number: 101

Brand Name15 ML MILLILITRE(S)
Product Code---
Date Received2020-02-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-26

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