MAUDE MDR 9253181

MDR report key
9253181
Report number
9611594-2019-00203
Event key
0
Event type
3
Date received
2019-10-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LISA CLARK
Address
5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US
Phone
470-470-4704
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERSDH EF PERC PLACEMENT PRODUCTSAVANOS MEDICAL INC.KGC98701109870103UNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-290

Event Narratives#

No narrative records found.