FDA.reportPublic FDA data

MAUDE MDR 9908358

MDR report key
9908358
Report number
2183959-2020-01783
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) PROCEDURE DUE TO UNSPECIFIED REASON. ALL COMPONENTS WERE REMOVED AND REPLACED DUE TO UNSPECIFIED REASON. NO INFORMATION ABOUT THE PATIENT'S OUTCOME WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED. THE PREVIOUS IPP WAS REPLACED DUE TO IT WOULD NOT INFLATE. THE SPECIFIC DEVICE MALFUNCTION IS UNKNOWN. THE PATIENT IS CURRENTLY RECOVERING.