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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 72404012
Device Problem Insufficient Information (3190)
Patient Problem Erosion (1750)
Event Date 11/13/2019
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) device was explanted because "one end of the device protruded from the glans penis." a new ipp device was implanted.Additional information received states only the cylinders and exited the patient's body.There was no infection present.Following the surgery the patient was "cured.".
 
Manufacturer Narrative
Device evaluation: the ams700 ipp cylinder was visually inspected and functionally tested; no leaks were found.The cylinder performed within specification.Device analysis was unable to confirm a device malfunction nor the reported allegation of extrusion.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device was explanted because "one end of the device protruded from the glans penis." a new ipp device was implanted.Additional information received states only the cylinders and exited the patient's body.There was no infection present.Following the surgery the patient was "cured.".
 
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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 Key9498087
MDR Text Key172092803
Report Number2183959-2019-68268
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002699
UDI-Public00878953002699
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 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/21/2023
Device Model Number72404012
Device Catalogue Number72404012
Device Lot Number1000039977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received01/17/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
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