FDA.reportPublic FDA data

MAUDE MDR 9900110

MDR report key
9900110
Report number
2183959-2020-01706
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-30
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
12020-03-3001. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO PUMP BEING HARD TO INFLATE/SQUEEZE WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER, PUMP, AND RESERVOIR WAS EXPLANTED AND A NEW IPP CYLINDER, PUMP, AND RESERVOIR WAS IMPLANTED. THE PATIENT IS HEALING FOLLOWING THE PROCEDURE.