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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Unspecified Infection (1930); Inflammation (1932)
Date of Event 01/01/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) device is going to be revised due to an infection.The patient "currently has a prosthesis-associated infection.The condition was confirmed with an ultrasound exam, which showed collection and inflammation, with drug treatment, the case was almost completely reversed, but requires surgical treatment.The proposed surgery is rescue surgery, trying to avoid the loss of the penile prosthesis, the patient is hospitalized receiving antibiotics and will be submitted to penile prosthesis rescue surgery on february 23rd.".
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Common Device Name
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9860963
Report Number2183959-2020-01449
Device Sequence Number2663767
Product Code FAE
UDI-Device Identifier00878953005249
UDI-Public00878953005249
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K090663
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2020
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
Operator of Device Lay User/Patient
Device Expiration Date08/30/2022
Device Model Number720056-02
Device Catalogue Number720056-02
Device Lot Number0187040001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/21/2020
Initial Report FDA Received Date03/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age82 YR
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