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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 720074-01
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Perforation (2001)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient had his spectra penile prosthesis (spp) removed and replaced due to an unspecified reason.No patient complications were reported in relation to this event.Additional information was received that this patient had his spp removed on an unknown date, and then on (b)(6) 2017, this patient was re-implanted with another spp.This patient had to have an emergency removal due to the device "went through the corpus cavernosum." it was added that ¿the patient¿s condition was serious and it was quite urgent.¿.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Common Device Name
PROSTHESIS, PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
MDR Report Key7220613
Report Number2183959-2018-00018
Device Sequence Number111406
Product Code FAE
UDI-Device Identifier00878953005270
UDI-Public00878953005270
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/10/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date02/25/2021
Device Catalogue Number720074-01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/10/2018
Initial Report FDA Received Date01/25/2018
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;
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