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

Model Number 720074-02

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 12/05/2019

Event Type  Injury  

Event Description

It was reported that the right cylinder of the ams spectra concealable penile prosthesis (spp) eroded through the patient's skin due to an infection.The spp was removed and replaced with a new tactra.Additional information received stated that the patient had the infection 3 weeks prior to the procedure and the exact date when it occurred it unknown to the physician.Also, the new tactra was not placed in the corpora where the infection occurred, but on the patient's left side without the erosion/infection.

• 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): AMERICAN MEDICAL SYSTEMS LLC; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9519759
• MDR Text Key: 172717894
• Report Number: 2183959-2019-68238
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• 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: 12/26/2019

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 Expiration Date: 02/02/2022
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 0163541001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR