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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404252-10
Device Problems Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588); Material Deformation (2976)
Patient Problems Capsular Contracture (1761); Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
The exact event date is unknown.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.
 
Event Description
It was reported that the patient had his inflatable penile prosthesis (ipp) implanted on (b)(6) 2020 and after some post operation sessions with his doctor and a company representative he has experienced persistent difficulties.The difficulties consist of a very arduous time squeezing the pump bulb through strong resistance (it fights back), only to achieve a semi-rigid erection, at about roughly an 80% angle.There is a lot of internal fibrous tissue surrounding the bulb and the deflation button, which makes it very hard to actuate them.After several painful and difficult squeezes, the erection arrives, but it is certainly not of the expected quality.The deflation button is even more difficult because of interfering fibrous tissue makes it difficult to localize, and the squeezing necessary to achieve deflation is very hard to do and can be quite painful.He typically achieves little to no deflation, and has to wait over a period of days for any meaningful deflation to occur over time.The patient indicates that he has taken oxycodones to be able to stand the pain when trying to use the deflation button, therefore, the patient has given up on any further usage of the device.The patient and his wife dislike that the penis has shortened significantly.The patient indicated that the doctor had to place the reservoir very low in his abdomen because excessive scarring from a previous abdominoplasty prevented placing it higher.The patient wonders if any of his difficulties could stem from long tubes with a short run, possibly creating kinks.The patient will continue follow up with his doctor.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key11003860
MDR Text Key221452402
Report Number2183959-2020-05878
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009810
UDI-Public00878953009810
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2020
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 Expiration Date09/01/2022
Device Model Number72404252-10
Device Catalogue Number72404252-10
Device Lot Number1000452239
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/21/2020
Initial Date FDA Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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