FDA.reportPublic FDA data

MAUDE MDR 9865499

MDR report key
9865499
Report number
3005099803-2020-00971
Event key
0
Event type
3
Date of event
2020-02-21
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOLYX SIS SYSTEMMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMABOSTON SCIENTIFIC CORPORATIONPAHM0068507000850-7000024250470R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

No narrative records found.