AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS 720074-01 manufactured by Boston Scientific Corporation.

Event Text Entries

[185914555] Event was reported for two related device. This mdr will be referenced on the second report. As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint. The reported allegations could not be confirmed. The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Patient Sequence No: 1, Text Type: N, H10


[185914556] It was reported that the patient indicated penis "pulling" to the right with an spectra penile prosthesis (spp). The suspected cause was scar tissue near the corpora. No surgical procedure has been performed. It was further reported that there were no device malfunctions associated with the device. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01773
MDR Report Key9908119
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-06-18
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALYSON HARRIS
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone4083953452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Generic NamePROSTHESIS PENILE
Product CodeFAE
Date Received2020-03-31
Model Number720074-01
Catalog Number720074-01
Lot Number1000119710
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address10700 BREN ROAD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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