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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 72404232-10
Device Problems Inflation Problem (1310); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of event and explant date: unknown, early (b)(6) 2020 is when issues started.
 
Event Description
It was reported that the patient underwent an ams 700 inflatable penile prosthesis (ipp) replacement surgery due to a failed pump.The pump was hard and would not inflate.No patient complications were reported in relation to this event and the patient was satisfactory post procedure.
 
Event Description
It was reported that the patient underwent an ams 700 inflatable penile prosthesis (ipp) replacement surgery due to a failed pump.The pump was hard and would not inflate.No patient complications were reported in relation to this event and the patient was satisfactory post procedure.
 
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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 Key11171417
MDR Text Key226838689
Report Number2183959-2021-00060
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009780
UDI-Public00878953009780
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 02/10/2021
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 Date09/16/2022
Device Model Number72404232-10
Device Catalogue Number72404232-10
Device Lot Number1000457193
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received01/14/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
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