FDA.reportPublic FDA data

MAUDE MDR 9746435

MDR report key
9746435
Report number
1810189-2020-00009
Event key
0
Event type
3
Date received
2020-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS STELLA PIETRAFESA
Address
235 E42ND STREET NEW YORK NY 10017 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GELFOAMSPONGE, STERILE; CLASS IIIPFIZER, INC. (DEVICE)LMF* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2401. O; 2. R

Event Narratives#

No narrative records found.