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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 ACCESSORY KIT; PROSTHESIS, PENIS, INFLATABLE

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BOSTON SCIENTIFIC CORPORATION AMS 700 ACCESSORY KIT; PROSTHESIS, PENIS, INFLATABLE Back to Search Results
Model Number 72401850
Patient Problems Bacterial Infection (1735); Pain (1994); Fluid Discharge (2686)
Event Date 12/05/2023
Event Type  malfunction  
Event Description
Patient with a recent penile prosthesis implant on [redacted date] and complicated by persistent scrotal pain followed by drainage 1-2 weeks post-op.Prosthesis ultimately explanted [redacted date] and now with multiple or cultures growing m fortuitum.
 
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Brand Name
AMS 700 ACCESSORY KIT
Type of Device
PROSTHESIS, PENIS, INFLATABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key18639524
MDR Text Key334524307
Report Number18639524
Device Sequence Number1
Product Code JCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number72401850
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2024
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer02/05/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/05/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient SexMale
Patient RaceWhite
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