Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE Back to Search Results
Model Number 72404324
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Complaint, Ill-Defined (2331)
Date of Event 01/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery because the right cylinder proximally came out of the corpora.The surgeon repaired the corpora and explanted the existing 4.0 cm rear tip extender (rte).The explanted 4.0 cm rte was replaced with a 3.0 cm rte.No patient complications were reported in relation to this event.The explanted 4.0 cm rte is not expected to be returned.Should additional information be received, or product be returned, a supplemental report will be filed upon completion of the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RTE SNAPCONE
Common Device Name
PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key8381802
Report Number2183959-2019-61191
Device Sequence Number19248597
Product Code FHW
UDI-Device Identifier00878953004082
UDI-Public00878953004082
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date04/17/2023
Device Model Number72404324
Device Catalogue Number72404324
Device Lot Number1000092127
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2019
Initial Report FDA Received Date03/01/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age71 YR
-
-