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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 Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to the device bends during sexual intercourse with an spectra penile prosthesis (spp).The spp was explanted and a new tactra malleable penile prosthesis was implanted.
 
Event Description
It was reported that the patient underwent a revision procedure due to the device bends during sexual intercourse with an spectra penile prosthesis (spp).The spp was explanted and a new tactra malleable penile prosthesis was implanted.Additional information was reported that the penis does not maintain rigidity during sexual intercourse and has to be molded to right rigidity every time, the physician believes this is from the spectra's particular design and malleability.The patient was stable following the procedure.
 
Manufacturer Narrative
Additional information: b5.
 
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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 Key9588351
MDR Text Key174953737
Report Number2183959-2019-68673
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 foreign,health professional
Type of Report Initial,Followup
Report Date 02/28/2020
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? 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 12/16/2019
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received02/14/2020
Supplement Dates FDA Received02/28/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 DA
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