Model Number UNK-P-IPP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
|
Event Date 11/21/2023 |
Event Type
Injury
|
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.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 with this inflatable penile prosthesis experienced scrotal edema with pain.The event was treated with unspecified medication.No information was provided regarding the patient outcome.
|
|
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.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 with this inflatable penile prosthesis experienced scrotal edema with pain.The event was treated with keflex medication.Medical assessment determined that the reported adverse events had casual relationship with the implant procedure and were not related to the device.The patient underwent surgery, the device was replaced with a tactra malleable prosthesis.There were no further reported patient complications.
|
|
Event Description
|
It was reported that the patient with this inflatable penile prosthesis experienced scrotal edema with pain and infection.The event was treated with keflex medication.Medical assessment determined that the reported adverse events had casual relationship with the implant procedure and were not related to the device.The patient underwent surgery, the device was replaced with a tactra malleable prosthesis.There were no further reported 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.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
|
Search Alerts/Recalls
|