Model Number UNK-P-IPP |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problem
Hernia (2240)
|
Event Date 12/09/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient with this inflatable penile prosthesis (ipp), presented with a hernia as a result of reservoir migration.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.There were no additional patient complications reported.
|
|
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.
|
|
Manufacturer Narrative
|
Corrected h6 device codes and b5 describe event.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 an inflatable penile prosthesis (ipp), presented with a hernia as a result of the reservoir being out of place.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.There were no additional patient complications reported.
|
|
Search Alerts/Recalls
|