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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problem Hernia (2240)
Event Date 12/09/2023
Event Type  Injury  
Event Description
It was reported that the patient with this inflatable penile prosthesis (ipp), presented with a hernia as a result of reservoir migration.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.There were no additional patient complications reported.
 
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Manufacturer Narrative
Corrected h6 device codes and b5 describe event.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the patient, with an inflatable penile prosthesis (ipp), presented with a hernia as a result of the reservoir being out of place.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.There were no additional patient complications reported.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18692456
MDR Text Key335186554
Report Number2124215-2024-08006
Device Sequence Number1
Product Code FHW
Combination Product (y/n)Y
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/08/2024
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 Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/24/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received05/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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