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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 Problems Collapse (1099); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the patient presented in the clinic with the pump not working.
 
Manufacturer Narrative
Device analysis: product analysis confirmed the reported allegation of pump not working.The returned pump failed the inflation test, while the report of a dimpled pump and the pump staying flat was not observed during the analysis, the identified functional failure indicates that the pump was not functioning correctly and it is probable that this malfunction manifested itself in the patient as a dimpled pump and is the most probable cause for the report of pump not working.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 through product analysis.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that the patient experienced dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the patient presented in the clinic with the pump not working.
 
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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 Key9310365
MDR Text Key166003749
Report Number2183959-2019-67425
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 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/24/2021
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number0147916002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received12/10/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
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