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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 Inadequacy of Device Shape and/or Size (1583)
Patient Problem Pain (1994)
Event Date 11/10/2023
Event Type  Injury  
Event Description
It was reported that the patient with this tactra malleable penile prosthesis was experiencing pain due to the device pressing on the skin.The left cylinder was removed and replaced with a shorter one.There were no additional patient complications.
 
Event Description
It was reported that the patient with this tactra malleable penile prosthesis was experiencing pain due to the device pressing on the skin.The left cylinder was removed and replaced with a shorter one.There were no additional patient complications.
 
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.The reason for pain and length too long were determined to be "inadvertent/unintentional interaction".The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that "inadvertent/unintentional interaction" was the most probable cause of the event.
 
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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
cashel road
clonmel
EI  
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18140193
MDR Text Key328169246
Report Number2124215-2023-63714
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 12/07/2023
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
Device Lot Number0040005870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received12/04/2023
Supplement Dates FDA Received12/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2022
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) Required Intervention; Hospitalization;
Patient Age49 YR
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