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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 Material Too Soft/Flexible (4007)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 07/10/2018
Event Type  Injury  
Event Description
It was reported the patient had his spectra penile prosthesis replace with an inflatable penile prosthesis as the patient was dissatisfied with the rigidity.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 Key7684792
MDR Text Key113868137
Report Number2183959-2018-00093
Device Sequence Number1
Product Code FAE
UDI-Device Identifier00878953005218
UDI-Public00878953005218
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 07/10/2018
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 Expiration Date10/04/2021
Device Catalogue Number720054-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2018
Initial Date FDA Received07/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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