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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 720082-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Date 10/15/2020
Event Type  Injury  
Event Description
It was reported that this patient underwent two separate procedures to drain cysts that formed on one side of their penis following implant of this tactra malleable penile prosthesis.The cylinder on the effected side of the penis was removed but not replaced; the opposite cylinder remains implanted.The patient was reported to have fully recovered.No additional patient complications were reported.
 
Manufacturer Narrative
Updated - h6: evaluation result codes, h6: evaluation conclusion codes.
 
Event Description
It was reported that this patient underwent two separate procedures to drain cysts that formed on one side of their penis following implant of this tactra malleable penile prosthesis.The cylinder on the effected side of the penis was removed but not replaced; the opposite cylinder remains implanted.The patient was reported to have fully recovered.No additional patient complications were reported.
 
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Brand Name
TACTRA MALLEABLE PENILE PROTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10749938
MDR Text Key213507483
Report Number2183959-2020-05129
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
PMA/PMN Number
K183619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/16/2020
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 Number720082-01
Device Catalogue Number720082-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received11/10/2020
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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