MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE

Model Number 720082-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 10/08/2020

Event Type  Injury  

Event Description

It was reported that this patient presented for emergent follow-up complaining of pain and swelling in the penis and scrotum with left distal erosion of the urethra and infection.It was noted that the infection may have been ongoing from previous removal of a non-boston scientific device approximately one month earlier.The right cylinder of this tactra malleable penile prosthesis was removed and the wound cleaned; the patient was also placed on antibiotics.No new device was implanted and the original right cylinder remains in place.The left cylinder will not be returned as it was discarded.The patient was reported to be well following the procedure.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10705848
• MDR Text Key: 212122969
• Report Number: 2183959-2020-04902
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0025074347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR