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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72401850
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/06/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to the cylinder strength being weak with an inflatable penile prosthesis (ipp).The ipp remains implanted and active and saline was added to the reservoir.The patient was stable following the procedure.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10756847
Report Number2183959-2020-05219
Device Sequence Number3486321
Product Code FHW
UDI-Device Identifier00878953001135
UDI-Public00878953001135
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/29/2020
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
Operator of Device Lay User/Patient
Device Expiration Date11/18/2023
Device Model Number72401850
Device Catalogue Number72401850
Device Lot Number1000194383
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date10/29/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age46 YR
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