Model Number 72404252-10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Hemorrhage/Bleeding (1888)
|
Event Date 10/25/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the patient experienced problems with this inflatable penile prosthesis (ipp), as after implant of a new pump, the patient experienced bleeding and it was found that the incision was open.The device was removed, and a malleable prosthesis was implanted.There were no further patient complications.
|
|
Manufacturer Narrative
|
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
|
Event Description
|
It was reported that the patient experienced problems with this inflatable penile prosthesis (ipp), as after implant of a new pump, the patient experienced bleeding and it was found that the incision was open.The device was removed, and a malleable prosthesis was implanted.
|
|
Search Alerts/Recalls
|