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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 720074-02
Device Problem Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Event Description
It was reported that a second cylinder was used due to a measurement error.A patient outcome was not reported.Further information has been requested and is not yet available.Should additional information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a second cylinder was used due to a measurement error.A patient outcome was not reported.Further information has been requested and is not yet available.Should additional information become available, a supplemental report will be submitted.Additional information received that the second cylinder was used due to miscalculation by the physician.There was no malfunction to be reported with the cylinder.The patient outcome was reported to be well.This occurred during an original surgery.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
Manufacturer Narrative
Additional information received that the second cylinder was used due to miscalculation by the physician.There was no malfunction to be reported with the cylinder.The patient outcome was reported to be well.This occurred during an original surgery.
 
Event Description
It was reported that a second cylinder was used due to a measurement error.A patient outcome was not reported.Further information has been requested and is not yet available.Should additional information become available, a supplemental report will be submitted.
 
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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 Key8552330
MDR Text Key143234845
Report Number2183959-2019-62606
Device Sequence Number1
Product Code FAE
UDI-Device Identifier00878953005287
UDI-Public00878953005287
Combination Product (y/n)N
PMA/PMN Number
K090663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2023
Device Model Number720074-02
Device Catalogue Number720074-02
Device Lot Number1000049899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Initial Date Manufacturer Received 03/29/2019
Initial Date FDA Received04/25/2019
Supplement Dates Manufacturer Received05/06/2019
06/10/2019
Supplement Dates FDA Received06/05/2019
06/17/2019
Patient Sequence Number1
Patient Age58 YR
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