MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 720074-01

Device Problem Insufficient Information (3190)

Patient Problem Scarring (2061)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Event was reported for two related device.This mdr will be referenced on the second report.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient indicated penis "pulling" to the right with an spectra penile prosthesis (spp).The suspected cause was scar tissue near the corpora.No surgical procedure has been performed.It was further reported that there were no device malfunctions associated with the device.No more information available at the moment.Should additional information become available, it will be provided.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9908119
• MDR Text Key: 185914555
• Report Number: 2183959-2020-01773
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 1000119710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR