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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 72404310
Device Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
Compoents not sent back for evaluation.
 
Event Description
It was reported that due to a pump malfunction or dimpling observed during operational testing after implant of the patient's inflatable penile prosthesis (ipp), a different pump was used to achieve the desired results.Additional information received that the pump stayed flat when pressing the bulb.The patient got well following this surgery.
 
Manufacturer Narrative
An allegation of pump collapse was reported.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and performed within specifications.Product analysis is unable to confirm the reported events.
 
Event Description
It was reported that due to a pump malfunction or dimpling observed during operational testing after implant of the patient's inflatable penile prosthesis (ipp), a different pump was used to achieve the desired results.Additional information received that the pump stayed flat when pressing the bulb.The patient got well following this surgery.
 
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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 Key9639764
MDR Text Key176751961
Report Number2183959-2020-00310
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/14/2024
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000232099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received02/21/2020
Patient Sequence Number1
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