FDA.reportPublic FDA data

MAUDE MDR 9908132

MDR report key
9908132
Report number
2183959-2020-01765
Event key
0
Event type
3
Date of event
2020-03-13
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 THE DEVICE WAS NOT WORKING. IT WOULD NOT INFLATE OR DELATE. ALL THE COMPONENTS WERE REMOVED AND REPLACED WITH A NEW IPP SYSTEM. NO INFORMATION ABOUT THE PATIENT'S OUTCOME WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED. ACCORDING TO THE PHYSICIAN THE IMPLANT WAS 10 YEARS OLD.