FDA.reportPublic FDA data

MAUDE MDR 9892051

MDR report key
9892051
Report number
8043484-2020-00222
Event key
0
Event type
3
Date of event
2020-03-02
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
DR SARAH FREESTONE
Address
101 HESSLE ROAD HULL HU3 2 UK
Phone
44-44-0447
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RENASYS TOUCHNEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPSMITH & NEPHEW MEDICAL LTD.OMPUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING HOMECARE A RENASYS TOUCH DEVICE GAVE A BLOCKAGE WARNING. AFTER CHANGING THE CANISTER, THE DEVICE WORKED BUT 5 MINUTES LATER IT DISPLAYED THE BLOCKAGE WARNING AGAIN. THE PATIENT WAS ADVISED TO CONSULT FOR A DRESSING CHANGE. NO BACK-UP WAS AVAILABLE. THE SERIAL NUMBER IS NOT AVAILABLE.