FDA.reportPublic FDA data

MAUDE MDR 9908038

MDR report key
9908038
Report number
2183959-2020-01771
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
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
ALYSON HARRIS
Address
10700 BREN ROAD W MINNETONKA MN 55343 US
Phone
408-408-4083
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
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT STATED THE PUMP WAS "AGONIZING" WHEN TRYING TO INFLATE AN INFLATABLE PENILE PROSTHESIS (IPP) EVEN TRYING TO USE NUMBING CREAM ON IT. THE PATIENT ALSO INDICATED THAT THE PHYSICIAN WAS AWARE OF THE PROBLEM. PRODUCT PERFORMANCE ANALYST (PPA) WAS UNABLE TO REQUEST FURTHER INFORMATION, AS CUSTOMER CONTACT FOR THE ACCOUNT IS UNKNOWN.