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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 03/06/2019
Event Type  Injury  
Manufacturer Narrative
Additional product component: model number/catalog number: 72404292 and 72404161, batch/lot number: 132414005 and 126062013, model/catalog description: lgx 15cm snap fit rt and reservoir 65ml pc.
 
Event Description
It was reported that the patient experienced a dimpled pump with an inflatable penile prosthesis (ipp).The ipp, cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
 
Manufacturer Narrative
Device analysis: pump was visually tested and leak tested, no defects detected.Functional test was conducted and pump was unable to inflate/activate test.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.Additional product component: model number/catalog number 72404292 and 72404161 serial number: null and null batch/lot number 132414005 and 126062013 model/catalog description lgx 15cm snap fit rt and reservoir 65ml pc.
 
Event Description
It was reported that the patient experienced a dimpled pump with an inflatable penile prosthesis (ipp).The ipp, cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
 
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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 Key8475384
MDR Text Key140676238
Report Number2183959-2019-61977
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/09/2021
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number0125035002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Date Manufacturer Received06/04/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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