MAUDE Adverse Event Report: COLOPLAST INFLATABLE PENILE PROSTHESIS

Model Number ER8125

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2017

Event Type  Injury  

Event Description

Fluid loss - there appears to be a break at the reservoir tubing.The pt opted to undergo replacement of the inflatable penile prosthesis.

• Brand Name: INFLATABLE PENILE PROSTHESIS
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST; matthews NC 28104
• MDR Report Key: 6913903
• MDR Text Key: 88235197
• Report Number: MW5072577
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ER8125
• Device Catalogue Number: ES8820
• Device Lot Number: 5585205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 105