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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE Back to Search Results
Model Number 720056-02
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported that, per the patient, this spectra penile prosthesis does not maintain sufficient rigidity and does not allow him to maintain an erection during intercourse.A revision surgery is planned.No patient complications were reported.
 
Event Description
It was reported that, per the patient, this spectra penile prosthesis does not maintain sufficient rigidity and does not allow him to maintain an erection during intercourse.A revision surgery is planned.No patient complications were reported.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
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
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key16702606
MDR Text Key312901213
Report Number2124215-2023-16312
Device Sequence Number1
Product Code FAE
UDI-Device Identifier00878953005249
UDI-Public00878953005249
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K090663
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 05/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/04/2022
Device Model Number720056-02
Device Catalogue Number720056-02
Device Lot Number0188994004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2017
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 Age60 YR
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