NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for NONE manufactured by .

Event Text Entries

[31796236] I had an outpatient procedure called a pouchoscopy. Two days later i developed a high fever and was admitted to the hospital for septic shock. I spent 12 days at (b)(6) hospital in (b)(6). This included four days in icu.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5057990
MDR Report Key5240142
Date Received2015-11-17
Date of Report2015-11-17
Date of Event2015-03-04
Date Added to Maude2015-11-20
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

Generic NameNONE
Product CodeGCQ
Date Received2015-11-17
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2015-11-17

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