MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720054-03

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 04/10/2015

Event Type  Injury  

Event Description

It was reported that the spectra penile prosthesis worked well for six months, but was then reported to be "loose." upon examination it was noted that there was a "loss of the distal end of the penis, making it difficult and sometimes prevents the penetration." there were no patient complications reported as a result of this event.

Event Description

Additional information received indicated that the patient had his spectra penile prosthesis removed and replaced due to the prosthesis "doesn't fit properly." there were no patient complications reported as a result of this event.

Manufacturer Narrative

Evaluation summary: two spectra malleable cylinders were visually inspected and functionally tested.Analysis results indicate the device performed within specifications.

Event Description

Additional information received indicated that "the patient didn't have the necessary sustention to penetrate" and "the device didn't migrate." there were no complications reported as a result of this event.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4727503
• MDR Text Key: 5738459
• Report Number: 2183959-2015-00167
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• 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,Followup,Followup
• Report Date: 04/02/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2015
• Device Catalogue Number: 720054-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2015; 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2010
• 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: 78 YR