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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 UNK-P-SPP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  Injury  
Event Description
It was reported that the patient had the spectra penile prosthesis removed as the patient was not satisfied with the device.Corpora reconstruction at left proximal was also reported.A new ambicor penile prosthesis consisting of 20 cm x 14 mm cylinders and pump were implanted.
 
Manufacturer Narrative
Additional information.
 
Event Description
It was reported that the patient had the spectra penile prosthesis removed as the patient was not satisfied with the device.Corpora reconstruction at left proximal was also reported.A new ambicor penile prosthesis consisting of 20 cm x 14 mm cylinders and pump were implanted.Additional information received indicated the patient had multiple implants with multiple revisions and the surgeon could not identify the left corpora.The physician used a biologic mesh to surgically reconstruct the left corpora so that he could insert a new implant.This was due to a pre-existing issue and not due to the spectra device.The patient did not like the appearance or the way the semi-rigid implant felt and desired to go back to a fluid filled device.Due to the patient's extensive medical history including a kidney transplant and an artificial urinary sphincter, the surgeon did not want to implant a device with a reservoir, therefore implanted the ambicor penile prosthesis.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Type of Device
PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8212740
MDR Text Key131929714
Report Number2183959-2018-62087
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/06/2019
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
Device Operator Lay User/Patient
Device Model NumberUNK-P-SPP
Device Catalogue NumberUNK-P-SPP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2018
Initial Date FDA Received01/03/2019
Supplement Dates Manufacturer Received01/09/2019
Supplement Dates FDA Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
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