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

Model Number 720056-02

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that the spectra penile prosthesis (spp) device is going to be revised due to an infection.The patient "currently has a prosthesis-associated infection.The condition was confirmed with an ultrasound exam, which showed collection and inflammation, with drug treatment, the case was almost completely reversed, but requires surgical treatment.The proposed surgery is rescue surgery, trying to avoid the loss of the penile prosthesis, the patient is hospitalized receiving antibiotics and will be submitted to penile prosthesis rescue surgery on february 23rd.".

• 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 ; 4089353452
• MDR Report Key: 9860963
• MDR Text Key: 184324282
• Report Number: 2183959-2020-01449
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

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: 08/30/2022
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 0187040001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR