FDA.reportPublic FDA data

MAUDE MDR 6523280

MDR report key
6523280
Report number
3005099803-2017-01221
Event key
0
Event type
3
Date received
2017-04-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
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
1UPSYLON?MESH, SURGICAL, SYNTHETICBOSTON SCIENTIFIC - MARLBOROUGHKOHUNK760R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-2601. O

Event Narratives#

D

Patient 1

AS REPORTED BY THE PATIENT?S ATTORNEY, A XENFORM? SOFT TISSUE REPAIR MATRIX (MFR REPORT #3005099803-2017-01222) AND AN UPSYLON Y MESH (MFR REPORT #3005099803-2017-01221) WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2015. 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.