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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 Deflation Problem (1149)
Patient Problem Pain (1994)
Event Date 10/21/2019
Event Type  Injury  
Event Description
It was reported that patient stated that his spectra penile prosthesis (spp) device will not bend out of the way.He walks around in pain as a result.Patient went to physician and he was unable to bend it either.Patient states his life is impacted daily by not having the ability to put my penis in a neutral position.No information about the patient outcome is available at the moment.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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key9309444
MDR Text Key165984899
Report Number2183959-2019-67386
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2019
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 Lay User/Patient
Device Model NumberUNK-P-SPP
Device Catalogue NumberUNK-P-SPP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/21/2019
Initial Date FDA Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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