MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONCEAL LOW PROFILE RESERVOIR WITH INHIBIZONE; PROSTHESIS, PENIS, INFLATABLE

Model Number 720185-01

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sepsis (2067); Urinary Retention (2119)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Patient presented to the hospital from his ltc facility complaining of urinary retention, pain, swelling and purulent drainage from his penis.Urology was consulted and found this 3-piece inflatable penile prosthesis was infected.This device had been implanted five years ago.The cylinder was found to have extrusion through the meatus and it was non-functionable.Patient became septic and required antibiotic therapy for 7 days.

• Brand Name: CONCEAL LOW PROFILE RESERVOIR WITH INHIBIZONE
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12280383
• MDR Text Key: 265164144
• Report Number: 12280383
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 144627011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Weight: 115