AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP manufactured by Boston Scientific Corporation.

Event Text Entries

[188481755] It was reported that the patient stated that he is very unhappy with his inflatable penile prosthesis (ipp) device. The patient said that his penis is soft and now curves down. The patient also reported that sometimes he experiences troubles inflating and deflating and would like to see someone for a second opinion. Patient was told that patient liaison will contact him. Additional information received. Patient liaison spent over 30 minutes talking with the patient and his wife educating them and leading them to edcure. Org to assist in finding a dr. For a second opinion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01788
MDR Report Key9908529
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-26
Date Mfgr Received2020-03-26
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALYSON HARRIS
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone4089353452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS INFLATABLE PENILE PROSTHESIS
Generic NameDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Product CodeFHW
Date Received2020-03-31
Model NumberUNK-P-IPP
Catalog NumberUNK-P-IPP
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address10700 BREN ROAD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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