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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 Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 12/05/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to unspecified reasons with an spectra penile prosthesis (spp).The spp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Additional information was reported that the patient experienced pain with the spp.
 
Event Description
It was reported that the patient underwent a revision procedure due to unspecified reasons with an spectra penile prosthesis (spp).The spp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Additional information was reported that the patient experienced pain with the spp.Additional information was reported that the patient experienced pain with the spp.And the patient recovered following the procedure.
 
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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 Key9530690
MDR Text Key173169920
Report Number2183959-2019-68381
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 health professional
Type of Report Initial,Followup
Report Date 01/23/2020
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? No
Device Operator Lay User/Patient
Device Expiration Date04/03/2024
Device Model Number720074-02
Device Catalogue Number720074-02
Device Lot Number1000257354
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received12/30/2019
Supplement Dates FDA Received01/23/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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