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 Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that spectra was removed on (b)(6) 2018, because of patient's dissatisfaction.A 16cmx 12mm ams ambicor penile prosthesis device was implanted.No further patient complications were reported in relation to this event.

Event Description

It was reported that the patient was dissatisfied with the 9.5mm x 16cm spectra penile prosthesis (spp).The spp was explanted and a 16cm x 12.5mm ambicor penile prosthesis was implanted.No further patient complications were reported in relation to this event.The complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint so an overall investigation conclusion code of no problem detected was chosen.No allegation(s) were reported.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.

• 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: 7958007
• MDR Text Key: 123449001
• Report Number: 2183959-2018-60039
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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: 09/11/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR