MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PR INSJ PENILE PROSTHESIS NON-INFLATABLE SEMI-RIGID; PROSTHESIS, PENILE

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 12/10/2020

Event Type  malfunction  

Event Description

Male patient with penile implant reporting unable to achieve or maintain an erection.Patient was admitted for planned surgery - removal & replacement of implant due to concern for defective implant.Per operative note, a hole was visualized in the left cylinder of the implant.

• Brand Name: PR INSJ PENILE PROSTHESIS NON-INFLATABLE SEMI-RIGID
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11130705
• MDR Text Key: 225514259
• Report Number: 11130705
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2020
• Event Location: Other
• Date Report to Manufacturer: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA