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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); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2020
Event Type  malfunction  
Event Description
It was reported that the patient is scheduled for a revision procedure due to the pump not working and the pump was sticky with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.
 
Event Description
It was reported that the patient is scheduled for a revision procedure due to the pump not working and the pump was sticky with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.Additional information was reported that the ipp pump was explanted and a new ipp pump was implanted on (b)(6) 2020.
 
Manufacturer Narrative
Device analysis: the returned device was analyzed and the reported allegations of pump not working and sticky pump was confirmed.Based on a review of all available information, the cause of the reported event could not be determined.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that the patient is scheduled for a revision procedure due to the pump not working and the pump was sticky with an inflatable penile prosthesis (ipp).The ipp remains implanted and active.Additional information was reported that the ipp pump was explanted and a new ipp pump was implanted on (b)(6) 2020.
 
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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 Key9844846
MDR Text Key183929063
Report Number2183959-2020-01370
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Date Manufacturer Received05/04/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
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