FDA.reportPublic FDA data

MAUDE MDR 9908532

MDR report key
9908532
Report number
2183959-2020-01785
Event key
0
Event type
3
Date of event
2020-03-11
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 HAS BEEN EXPERIENCING PUMPING ISSUES WITH HIS INFLATABLE PENILE PROSTHESIS (IPP). THE PATIENT STATED THAT IT DOESN'T WANT TO INFLATE ALL THE WAY AFTER 10-15 PUMPS. THE PUMP IS NOT DEPRESSING ALL THE WAY WHEN SQUEEZING. THE PATIENT ALSO REPORTED THAT WHEN HE GETS IT TO ITS FULL LENGTH BUT IT IS STILL SOFT, AFTER 75-80 PUMPS. IT WAS FURTHER REPORTED THAT THE PATIENT CURRENTLY HAS A MALLEABLE DEVICE IMPLANTED.