AMS INFLATABLE PENILE PROSTHESIS 72404013

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for AMS INFLATABLE PENILE PROSTHESIS 72404013 manufactured by Boston Scientific Corporation.

Event Text Entries

[185914776] It was reported that the patient had previously had a coloplast device implanted. A revision surgery was scheduled at which time the cylinders were being replaced with bsc ipp cylinders. The first pair of bsc ipp cylinders were not used due to a measurement error. Another pair of cylinders were used to complete the surgery. There is no indication of a device malfunction or issue with the bsc ipp device. Additional information received clarified that the patient previously had a bsc inflatable penile prosthesis (ipp) device implanted. The cylinders of the ipp device were explanted due to pain. When implanting the new ipp device one pair of ipp cylinders were not used due to a measurement error. Another pair of cylinders were used to complete the surgery. There were no further patient complications for this case. Further additional information received states the pain was in the "glans penis. " no other treatments or interventions were tried to address the pain. The physician does not believe that the device caused or contributed to the pain. The patient was doing well following the surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01764
MDR Report Key9908114
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-03-14
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 Number72404013
Catalog Number72404013
Lot Number1000243038
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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