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

Model Number UNK-P-SPP

Device Problem Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Event Description

It was reported that the patient was implanted with a spectra penile prosthesis (spp).Distal right tip of implant began to migrate laterally.Spectra was removed and tactra penile implant was implanted.Right distal corpora was repaired and reinforced.The patient is recovering.

• 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: 10183732
• MDR Text Key: 196071808
• Report Number: 2183959-2020-02634
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/23/2020

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 Model Number: UNK-P-SPP
• Device Catalogue Number: UNK-P-SPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• 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: 40 YR