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 health professional report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS UNK-P-IPP manufactured by Boston Scientific Corporation.

Event Text Entries

[185938325] It was reported that the patient underwent a surgical procedure involving an inflatable penile prosthesis (ipp) due to the pump "staying down". During the procedure the existing device was removed and a new ipp was implanted. A leak was identified in the tubing near the pump. No information was provided about the patient's outcome. It was further reported that the perforation was identified once the pump was removed. The hole occurred after the device was in use. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01790
MDR Report Key9908534
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-12
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 Phone4083953452
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
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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