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 AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
  • 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 AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-IPP
Device Problems Defective Device (2588); Malposition of Device (2616)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/25/2020
Event Type  Injury  
Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
Event Description
It was reported that the patient stated the existing inflatable penile prosthesis (ipp) inflates and deflates okay but one of the cylinders felt "too far out in the head" hurting the patient's wife during intercourse by gouging her and causing bleeding.The patient communicated with the physician and scheduled an appointment for (b)(6) 2020.Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.
 
Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
Event Description
It was reported that the patient stated the existing inflatable penile prosthesis (ipp) inflates and deflates okay but one of the cylinders felt "too far out in the head" hurting the patient's wife during intercourse by gouging her and causing bleeding.The patient communicated with the physician and scheduled an appointment for (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9950855
MDR Text Key187882351
Report Number2183959-2020-01994
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 consumer
Type of Report Initial,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
-
-