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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 720081-01
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  Injury  
Event Description
It was reported that the patient had the tactra penile prosthesis removed due to unspecified reasons.A new tactra penile prosthesis was implanted.No patient complications were reported.
 
Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
 
Manufacturer Narrative
This report is being submitted to provide additional information indicating there was no revision or intervention involving the device in question.The event was reported in error and corresponds to an initial implant procedure.There were no patient complications nor device performance allegations.
 
Event Description
It was reported that the patient had the tactra penile prosthesis removed due to unspecified reasons.A new tactra penile prosthesis was implanted.Additional information was later received clarifying the patient did not have their tactra replaced and the submitted information was for an original implant.No 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key15595331
MDR Text Key301645536
Report Number2124215-2022-41210
Device Sequence Number1
Product Code FAE
UDI-Device Identifier08714729979357
UDI-Public08714729979357
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K183619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/13/2022
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? No
Device Operator Lay User/Patient
Device Model Number720081-01
Device Catalogue Number720081-01
Device Lot Number0027728721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2022
Initial Date FDA Received10/13/2022
Supplement Dates Manufacturer Received10/13/2022
Supplement Dates FDA Received10/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
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 Age65 YR
Patient SexMale
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