FDA.reportPublic FDA data

MAUDE MDR 9903204

MDR report key
9903204
Report number
2183959-2020-01746
Event key
0
Event type
3
Date of event
2020-01-01
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 PROSTHESIS WITH INHIBIZONEDEVICE IMPOTENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONFHW72404233724042331000218956R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS CYLINDERS REMOVED DUE TO A BULGE ON THE LEFT OUTER PROXIMAL PENIS SHAFT FOUND TO BE FROM TOO LONG CYLINDER FROM INCORRECT MEASUREMENT COMPOUNDED BY A PLACQUE. IMPLANT INFLATED FINE BUT FELT BULGE AROUND OUTER EDGE OF PENIS. THE PLAQUE WAS EXCISED AND A NEW 1 CM SHORTER CYLINDER WAS INSERTION. NO FURTHER ISSUE.