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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 Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2020
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) reservoir was explanted because it was "malpositioned/migrated." a new ipp reservoir was spliced into the existing pump.
 
Manufacturer Narrative
Additional information updated in b5: this report is a duplicate event and is reported under mfr# 2183959-2020-05384 and the analysis will be submitted after completion under mfr# 2183959-2020-05384.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) reservoir was explanted because it was "malpositioned/migrated." a new ipp reservoir was spliced into the existing pump.This report is a duplicate event and is reported under mfr# 2183959-2020-05384 and the analysis will be submitted after completion under mfr# 2183959-2020-05384.
 
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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 Key11131059
MDR Text Key225504484
Report Number2183959-2020-06296
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 health professional
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
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? No
Date Manufacturer Received01/12/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
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