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

Model Number 720074-03

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 12/02/2020

Event Type  Injury  

Event Description

It was reported that the patient had a work accident which caused the spectra inflatable penile prosthesis to erode through his penis.The implant was removed in (b)(6) 2019.A tactra 9.5mm was implanted on (b)(6) 2020.The patient was doing fine following the reimplant 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11061582
• MDR Text Key: 223372769
• Report Number: 2183959-2020-06056
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• 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: 12/22/2020

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: 06/20/2021
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0141133005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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