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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 720185-01
Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Migration (4003)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 11/17/2020
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) device migrated out of its position.It was thought the reservoir tubing had coiled when the device migrated, and hindered the pump flow.The device was also thought to be short, so the entire device was explanted and a new ipp was implanted.
 
Manufacturer Narrative
Patient identifier - updated.Date of birth- updated.Sex - updated.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device migrated out of its position.It was thought the reservoir tubing had coiled when the device migrated, and hindered the pump flow.The device was also thought to be short, so the entire device was explanted and a new ipp was implanted.
 
Manufacturer Narrative
Patient identifier - updated.Date of birth- updated.Sex - updated.31jan2021 device and patient codes updated.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device migrated out of its position.The reservoir tubing had coiled when the device migrated, and hindered the pump flow.The device was also thought to be short, so the entire device was explanted and a new ipp was implanted.No other information was 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 Key10978821
MDR Text Key220527145
Report Number2183959-2020-05835
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953005669
UDI-Public00878953005669
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,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/30/2020
Device Model Number720185-01
Device Catalogue Number720185-01
Device Lot Number1000140887
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2021
Patient Sequence Number1
Treatment
1000189437CYLINDERS, PUMP; 1000189437CYLINDERS, PUMP; 72404230/1000189437CYLINDERS, PUMP; 1000189437CYLINDERS, PUMP
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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