MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 3 PIECE PENILE IMPLANT; PROSTHESIS, PENIS, INFLATABLE

Device Problem Output Problem (3005)

Patient Problems Pain (1994); Depression (2361)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Device stopped working and only action will be surgery to remove and replace.Which will cost money i don't have in addition to pain, suffering, mental depression, and humiliation.It's a penile implant device that don't work anymore and needs surgery to correct.Fda safety report id# (b)(4).

• Brand Name: AMS 3 PIECE PENILE IMPLANT
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12066695
• MDR Text Key: 258732436
• Report Number: MW5102139
• Device Sequence Number: 1
• Product Code: JCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 124