• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

  • 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
 

COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ESR8182400
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem No Code Available (3191)
Event Date 06/27/2017
Event Type  Injury  
Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to the available information, fluid loss, break in tubing pump to reservoir.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
(2BO)TITAN OTR INFRA ZERO ANG
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, MN 55411
6123024983
MDR Report Key7369895
MDR Text Key103440130
Report Number2125050-2018-00253
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932487542
UDI-Public05708932487542
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 03/22/2018
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? No
Device Operator Lay User/Patient
Device Model NumberESR8182400
Device Catalogue NumberESR8182400
Device Lot Number3634120
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/06/2018
Initial Date FDA Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
-
-