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AMS INFLATABLE PENILE PROSTHESIS Adverse Event — Injury (MDR 2183959-2020-02150)

AMS INFLATABLE PENILE PROSTHESIS Adverse Event — Injury (MDR 2183959-2020-02150) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AMS INFLATABLE PENILE PROSTHESIS; Generic name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.

DeviceAMS INFLATABLE PENILE PROSTHESIS
Generic nameDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
ManufacturerBOSTON SCIENTIFIC CORPORATION
Report number2183959-2020-02150
Event typeInjury
Product problemY
Date received2020-04-28
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeIT WAS REPORTED THAT TWO WEEKS PRIOR TO (B)(6) 2020 THE PATIENT PRESENTED WITH HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE NOT WORKING PROPERLY. TESTING IDENTIFIED THERE WAS A CRACK IN THE "PUMP CONNECTION TUBE." THE IPP PUMP WAS EXPLANTED ON (B)(6) 2020 AND A NEW IPP PUMP WAS IMPLANTED.
SourceopenFDA MAUDE (device adverse events)

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