GELCLAIR GEL PAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for GELCLAIR GEL PAP manufactured by Helsinn Healthcare.

Event Text Entries

[105969680] Disease progression. Therapy start date: (b)(6) 2018. Therapy end date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076530
MDR Report Key7439440
Date Received2018-04-17
Date of Report2018-04-16
Date of Event2018-04-16
Date Added to Maude2018-04-18
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGELCLAIR GEL PAP
Generic NameDRESSING, WOUND AND BURN
Product CodeMGQ
Date Received2018-04-17
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerHELSINN HEALTHCARE


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-17

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