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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE
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BOSTON SCIENTIFIC - MINNETONKA AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE Back to Search Results
Catalog Number 720054-02
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 11/02/2017
Event Type  Injury  
Event Description
It was reported the patient had his spectra penile prosthesis replaced with an inflatable penile prosthesis due to "product migration." no patient complications were reported in relation to this event.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Type of Device
PROSTHESIS, PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key7005510
MDR Text Key91184647
Report Number2183959-2017-00100
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/06/2016
Device Catalogue Number720054-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2011
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 Age64 YR
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