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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404267
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: 720185-01, batch/lot number: 704281020, model/catalog description: reservoir flat iz 100 ml.
 
Event Description
It was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.
 
Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: null, batch/lot number: 704281020.Model/catalog description: reservoir flat iz 100 ml.Product investigation summary: it was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.Analysis of the cxr preconnect ms 14cm ip iz confirmed there were no leaks in cylinder 1.Cylinder 2 had a leak at the cylinder body due to a hole in the outer tube and wear at the fold.The pump had no significant damage.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for tcf 700624 found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Ship history, labeling review and risk review not required per 92186855 wi cis product investigation.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.
 
Event Description
It was reported that the patient experienced spontaneous inflation with an inflatable penile prosthesis (ipp).A replacement surgery was performed.The patient was concerned about a possible infection, but it was confirmed that the patient did not present signs of infection.The patient was reported to be fine after the procedure.No more information available at the moment.Should additional information become available, it will be provided.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8625595
MDR Text Key145559400
Report Number2183959-2019-63271
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003757
UDI-Public00878953003757
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/02/2013
Device Model Number72404267
Device Catalogue Number72404267
Device Lot Number700624003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Date Manufacturer Received06/05/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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