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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 72404232
Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
Event Type  Injury  
Event Description
It was reported that the patient went to his physician because he was unable to cycle his inflatable penile prosthesis (ipp).The physician decided to perform a revision.During the revision surgery the physician tried to pass fluid from a syringe into the reservoir at which point he identified there was a hole in the tubing at the base of the reservoir.The surgeon then decided to explant the entire ipp and implant a new device.The patient is expected to fully recover.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key10695622
MDR Text Key211845701
Report Number2183959-2020-04772
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003450
UDI-Public00878953003450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/25/2018
Device Model Number72404232
Device Catalogue Number72404232
Device Lot Number0135596005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL 720185-01,LOT 0162807014
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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