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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 72404310
Device Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to 'dimpled pump' the pump remains flat when pressed, and the device did not work properly that began two weeks prior to revision with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.
 
Event Description
It was reported that the patient underwent a revision procedure due to 'dimpled pump' the pump remains flat when pressed, and the device did not work properly that began two weeks prior to revision with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.
 
Manufacturer Narrative
Correction: g3.Device analysis:the returned device was analyzed and the reported allegations of dimpled pump was confirmed.Based on a review of all available information, the cause of the reported event was due to failing the activation test.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.
 
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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 Key10242839
MDR Text Key197910816
Report Number2183959-2020-02838
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/27/2021
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number132419005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
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