FLEXITOUCH SYSTEM PD32-U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-20 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Inc.dba Tactile Medical.

MAUDE Entry Details

Report Number3004183730-2019-00002
MDR Report Key9099849
Report SourceCONSUMER
Date Received2019-09-20
Date of Report2019-08-20
Date of Event2017-11-15
Date Mfgr Received2019-08-20
Date Added to Maude2019-09-20
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 ContactBRETT DEMCHUK
Manufacturer Street151 5TH AVENUE NW
Manufacturer CityNEW BRIGHTON MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6123555135
Manufacturer G1TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL
Manufacturer Street151 5TH AVENUE NW
Manufacturer CityNEW BRIGHTON MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXITOUCH SYSTEM
Generic NamePNEUMATIC COMPRESSION DEVICE
Product CodeJOW
Date Received2019-09-20
Model NumberPD32-U
Catalog NumberPD32-U
Lot Number11145, 17023, 113340
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL
Manufacturer Address151 5TH AVENUE NW NEW BRIGHTON MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-20

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