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

Model Number UNK-P-SPP

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  Injury  

Event Description

It was reported that the patient had the spectra penile prosthesis removed due to unspecified reasons.A new 20 cm x 12 mm spectra penile prosthesis was implanted.

Manufacturer Narrative

Additional and corrected data event.

Event Description

It was reported that the patient had the spectra penile prosthesis removed due to unspecified reasons.A new 20 cm x 12 mm spectra penile prosthesis was implanted.Additional information received indicated this was the patient's first surgery and not a revision surgery.

• 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
• MDR Report Key: 8165379
• MDR Text Key: 130375228
• Report Number: 2183959-2018-61687
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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 Model Number: UNK-P-SPP
• Device Catalogue Number: UNK-P-SPP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR