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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 UNK-P-IPP
Device Problems Collapse (1099); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2019
Event Type  Injury  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported that due to fluid loss from cylinders the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump and reservoir were implanted.It was further reported that the pump remained collapsed.
 
Manufacturer Narrative
Fluid loss and pump collapse were reported.The ams700 device was visually inspected and functionally tested.There was a leak in both cylinders that was the result of sharp instrument damage consistent with explant damage.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Correction to g1, h2, h3, and h6: updated to include device analysis.
 
Event Description
It was reported that due to fluid loss from cylinders the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump and reservoir were implanted.It was further reported that the pump remained collapsed.
 
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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 Key8922921
MDR Text Key155273577
Report Number2183959-2019-65805
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Date Manufacturer Received10/02/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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