MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 72400452

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: date of event entered is an estimated date as the exact date of event was not provided.

Event Description

It was reported that the malleable penile prosthesis (mpp) device is going to be revised due to a "proximal fracture" of the device."the patient was submitted to implantation of semi-rigid prosthesis on (b)(6) 2013, a year ago the prosthesis fracture was diagnosed, the radiograph shows the point of the proximal fracture compatible with the physical examination and since then the patient can not perform relations satisfactorily, and prosthesis replacement is necessary." additional information received states no interventions have been scheduled yet.

• Brand Name: AMS MALLEABLE 600 AND 600M 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: 9514283
• MDR Text Key: 175445885
• Report Number: 2183959-2019-68309
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K912935
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2014
• Device Model Number: 72400452
• Device Catalogue Number: 72400452
• Device Lot Number: 600092010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR