PREVENA PLUS DUO? PEEL PLACE? PRE3321US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for PREVENA PLUS DUO? PEEL PLACE? PRE3321US manufactured by Kci Usa, Inc..

MAUDE Entry Details

Report Number9391785
MDR Report Key9391785
Date Received2019-11-29
Date of Report2019-11-20
Date of Event2019-08-28
Report Date2019-11-20
Date Reported to FDA2019-11-20
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREVENA PLUS DUO? PEEL PLACE?
Generic NameNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Product CodeOMP
Date Received2019-11-29
Model NumberPRE3321US
Catalog NumberPRE3321US
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKCI USA, INC.
Manufacturer Address12930 IH 10 WEST SAN ANTONIO TX 78249 US 78249


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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