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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 Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2018
Event Type  malfunction  
Event Description
It was reported that during an original spectra penile prosthesis implant surgery, a 12 mm x 16 cm cylinder was tried and not used as it failed due to a measurement error.A second spectra penile prosthesis 9.5 mm x 16 cm cylinder was implanted.The event resolved.
 
Event Description
It was reported that during an original spectra penile prosthesis implant surgery, a 12 mm x 16 cm cylinder was tried and not used as it failed due to a measurement error.A second spectra penile prosthesis 9.5 mm x 16 cm cylinder was implanted.The event resolved.
 
Event Description
It was reported that during an original spectra penile prosthesis implant surgery, a 12 mm x 16 cm cylinder was tried and not used as it failed due to a measurement error.A second spectra penile prosthesis 9.5 mm x 16 cm cylinder was implanted.The event resolved.Additional information received indicated the labeling was correct and the physician miscalculated the size.
 
Manufacturer Narrative
Device evaluation: the spectra cylinders were visually inspected and functionally tested.They performed within specifications.
 
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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 Key8141958
MDR Text Key129608923
Report Number2183959-2018-61447
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 04/30/2019
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 Date01/12/2023
Device Model Number720074-02
Device Catalogue Number720074-02
Device Lot Number1000037559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Initial Date Manufacturer Received 11/09/2018
Initial Date FDA Received12/07/2018
Supplement Dates Manufacturer Received12/11/2018
04/01/2019
Supplement Dates FDA Received01/10/2019
04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
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