FDA.reportPublic FDA data

MAUDE MDR 9901491

MDR report key
9901491
Report number
2183959-2020-01736
Event key
0
Event type
3
Date of event
2020-03-13
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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 AMBICOR PENILE PROSTHESISDEVICE IMPOTENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONFHW72401455724014551000326385R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

N

Patient 1

AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED.

D

Patient 1

IT WAS REPORTED THAT PATIENT COMPLAINTS HIS AMBICOR PENILE PROSTHESIS (APP) PUMP IS ROCK HARD. PATIENT LIAISON EXPLAINED THAT HE MAY STILL BE EXPERIENCING SOME POST OP EDEMA AROUND THE PUMP AND THAT WILL LIKELY CONTINUE TO DIMINISH WITH MORE TIME (HE SAID DR. MOY ALSO TOLD HIM THIS.) HE IS VERY CONFUSED ABOUT WHAT TO EXPECT FROM HIS DEVICE. HE HAS AN UPCOMING APPOINTMENT WITH DR. MOY ON (B)(6) 2020.