FDA.reportPublic FDA data

MAUDE MDR 6959332

MDR report key
6959332
Report number
3005099803-2017-03078
Event key
0
Event type
3
Date received
2017-10-18
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
EMP. NANCY CUTINO
Address
100 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
1XENFORM SOFT TISSUE REPAIR MATRIXMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PROBOSTON SCIENTIFIC - MARLBOROUGHPAJUNK166R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-1801. O

Event Narratives#

D

Patient 1

AS REPORTED BY THE PATIENT?S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.