FDA.reportPublic FDA data

MAUDE MDR 8771976

MDR report key
8771976
Report number
1119193-2019-00029
Event key
0
Event type
3
Date of event
2019-07-05
Date received
2019-07-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDA WISOWATY
Address
2000 HOLLISTER DRIVE LIBERTYVILLE. 60048 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FITNEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FITHOLLISTER INCORPORATEDEXB14604UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-0901. R

Event Narratives#

No narrative records found.