MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number UNK-P-IPP

Device Problems Degraded (1153); Inflation Problem (1310)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 07/15/2019

Event Type  Injury  

Event Description

It was reported that the patient indicated experiencing a "botched" penile implant surgery.The patient reported still experiencing pain 6 weeks after surgery and not being able to urinate on his own, having to be catheter.The implant was said to only pump once and then it "locks up".The patient also noticed a bulge on the side of the penis.Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.No more information available at the moment.Should additional information become available, it will be provided.Additional information was received, the patient confirmed the implant was an inflatable penile prosthesis (ipp).It was further expressed that the patient penis was "disfigured", and had lost 4-5 inches in length.No more information available at the moment.Should additional information become available, it will be provided.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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 ; 4083953452
• MDR Report Key: 8848130
• MDR Text Key: 152853945
• Report Number: 2183959-2019-65429
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention