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

Model Number UNK-P-IPP

Device Problem Degraded (1153)

Patient Problem Pain (1994)

Event Date 07/06/2020

Event Type  Injury  

Event Description

It was reported that the patient called to report an approx two week onset of a bulge at the left base of his penis; he feels like it is a cylinder and states that it is painful; he also reports that his girlfriend states that he has lost length since the onset of the bulge; he states that he has seen his dr.About this problem and the dr said to wait and see; he asked if this was normal and patient liaison recommended that he speak again about it with his dr.He has an upcoming appointment in two weeks and will contact patient liaison after that appointment if he needs assistance in finding a dr.For a second opinion.

• 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 west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10390432
• MDR Text Key: 202361703
• Report Number: 2183959-2020-03465
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2020

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 Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/11/2020
• 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 Age: 69 YR