M?LNLYCKE Z-FLEX HEEL BOOT 1400122

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for M?LNLYCKE Z-FLEX HEEL BOOT 1400122 manufactured by Molnlycke.

MAUDE Entry Details

Report Number3004763499-2019-00008
MDR Report Key9050935
Date Received2019-09-13
Date of Report2019-05-31
Date of Event2019-03-27
Date Mfgr Received2019-08-15
Date Added to Maude2019-09-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS PAT STRAHL
Manufacturer Street5500 PEACHTREE PARKWAY SUITE 500
Manufacturer CityNORCROSS GA 30092
Manufacturer CountryUS
Manufacturer Postal30092
Manufacturer Phone4703750171
Manufacturer G1MOLNLYCKE
Manufacturer Street5500 PEACHTREE PARKWAY SUITE 500
Manufacturer CityNORCROSS GA 30092
Manufacturer CountryUS
Manufacturer Postal Code30092
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameM?LNLYCKE Z-FLEX HEEL BOOT
Generic NameFLUIDIZED HEEL BOOT
Product CodeFMP
Date Received2019-09-13
Model Number1400122
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMOLNLYCKE
Manufacturer Address5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-13

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