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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 Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  Injury  
Event Description
It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp) due to device no longer working.All components were explanted and replaced.
 
Event Description
It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp) due to device no longer working.All components were explanted and replaced.Additional information was received.Device had fluid loss due to hole in tubing.Pump went flat upon cycling.
 
Manufacturer Narrative
Field change: b5, h3, h6, h10.
 
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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 Key9865066
MDR Text Key184447115
Report Number2183959-2020-01472
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 03/31/2020
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 Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/02/2020
Initial Date FDA Received03/23/2020
Supplement Dates Manufacturer Received03/23/2020
Supplement Dates FDA Received03/31/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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