FDA.reportPublic FDA data

MAUDE MDR 9756653

MDR report key
9756653
Report number
9611594-2020-00034
Event key
0
Event type
3
Date of event
2020-01-14
Date received
2020-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATORDH EF PERC PLACEMENT PRODUCTSAVANOS MEDICAL INC.KGC98431N/AAA8008R04N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

No narrative records found.