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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404013
Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/15/2020
Event Type  Injury  
Event Description
It was reported that inflatable penile prosthesis (ipp) device had fluid loss.Patient underwent a surgical procedure where his ipp was explanted and a spectra penile prosthesis (spp) was implanted.Patient was stable after procedure and no adverse patient effects were reported.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegations of fluid leak and mechanical issue were not confirmed via product analysis.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.Both cylinders had wear at fold in cylinder body.This wear would not affect the functionality of device.Both cylinders were pressure tested and performed within specification.Based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that inflatable penile prosthesis (ipp) device had fluid loss.Patient underwent a surgical procedure where his ipp was explanted and a spectra penile prosthesis (spp) was implanted.Patient was stable after procedure and no adverse patient effects were reported.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11097805
MDR Text Key224515108
Report Number2183959-2020-06189
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002705
UDI-Public00878953002705
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/06/2022
Device Model Number72404013
Device Catalogue Number72404013
Device Lot Number0190580006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
1000047577; 1000047577; 187828006; 187828006
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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