ISOGEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for ISOGEL manufactured by Stryker Corporation.

Event Text Entries

[126943722] Stryker isogel mattress was compromised and not appropriate for patients, switched out for clean bed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8063657
MDR Report Key8063657
Date Received2018-11-13
Date of Report2018-10-31
Date of Event2018-10-19
Report Date2018-10-31
Date Reported to FDA2018-10-31
Date Reported to Mfgr2018-11-13
Date Added to Maude2018-11-13
Event Key0
Report Source CodeUser Facility 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 Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameISOGEL
Generic NameBED, FLOTATION THERAPY, POWERED
Product CodeIOQ
Date Received2018-11-13
Model NumberISOGEL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CORPORATION
Manufacturer Address3800 E. CENTRE AVE. PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-13

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