MAUDE Adverse Event Report: PENILE PUMP; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 07/01/2017

Event Type  No Answer Provided  

Event Description

Reporter is reporting on 3 penile prosthesis pumps.He states that since implantation it has been causing pain and difficulty urinating.He is unsure of the device manufacturer and of the implant dates of the first 2 pumps, but the third was implanted in (b)(6) of 2017.

• Brand Name: PENILE PUMP
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• MDR Report Key: 8389811
• MDR Text Key: 137853525
• Report Number: MW5084625
• Device Sequence Number: 3
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/04/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR