FDA.reportPublic FDA data

MAUDE MDR 9908266

MDR report key
9908266
Report number
2183959-2020-01781
Event key
0
Event type
3
Date of event
2020-03-16
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ALYSON HARRIS
Address
10700 BREN ROAD W MINNETONKA MN 55343 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMS INFLATABLE PENILE PROSTHESISDEVICE IMPOTENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONFHWUNK-P-IPPUNK-P-IPPR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT'S WIFE STATED THAT SHE AND HER HUSBAND MOVED AND NEED A LIST OF DOCTORS IN HER AREA WHO WOULD BE FAMILIAR WITH THE AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) HAS HER HUSBAND WAS IMPLANTED ABOUT 10 YEARS AGO AND IS HAVING SOME ISSUE WITH IT. SHE WAS ASSISTED WITH GUIDANCE TO FIND AN UROLOGIST IN HER AREA.