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

Catalog Number 720054-01

Device Problem Incorrect Measurement (1383)

Patient Problem Pain (1994)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported that the patient's spectra penile prosthesis, 12cm x 9.5mm with 3.5cm rear-tip extenders, was replaced due to a "measurement error".The physician indicated the measurement was too long and the patient had pain in the "end of the penis" because of "very tight insert".An inflatable penile prosthesis, 18cm x 12mm with 1.5cm rear-tip extenders, was implanted.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Analysis results: the two spectra cylinders were visually inspected and functionally tested.Both the cylinders performed within specifications.

• 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: 4785525
• MDR Text Key: 5877935
• Report Number: 2183959-2015-00202
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2018
• Device Catalogue Number: 720054-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2013
• 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: 60 YR