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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE Back to Search Results
Model Number 720080-01
Device Problem Material Deformation (2976)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 06/24/2022
Event Type  Injury  
Event Description
It was reported that the patient underwent a surgical procedure to remove this tactra device, since it was completely non-functional.It was noted that the patient experienced pain and discomfort and the device was bent and crooked upon explant.The device was replaced with an inflatable penile prosthesis.There were no additional patient complications reported.
 
Event Description
It was reported that the patient underwent a surgical procedure to remove this tactra device, since it was completely non-functional.It was noted that the patient experienced pain and discomfort and the device was bent and crooked upon explant.The device was replaced with an inflatable penile prosthesis.There were no additional patient complications reported.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this tactra underwent a thorough analysis.The cylinders were visually and microscopically examined.No anomalies were found with the cylinders.Based on the information available and analysis results, it was not possible to confirm the reported clinical observations regarding the device.Pain and discomfort are included as potential adverse events in patient labeling.
 
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Brand Name
TACTRA MALLEABLE PENILE PROTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15019861
MDR Text Key295950023
Report Number2124215-2022-25680
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/01/2022
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 Number720080-01
Device Catalogue Number720080-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/14/2022
Supplement Dates Manufacturer Received07/19/2022
Supplement Dates FDA Received08/01/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age81 YR
Patient SexMale
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