• 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 SCROT 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 SCROT ZERO ANG INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ESR9182400
Device Problems Tube (525); Hole In Material (1293)
Patient Problem No Information (3190)
Event Date 04/20/2017
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. See attached letter from fda dated 06/23 indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(4) program. Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.

 
Event Description

According to the available information, hole in tubing.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name(2BO)TITAN OTR SCROT ZERO ANG
Type of DeviceINFLATABLE 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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6739090
MDR Text Key80868515
Report Number2125050-2017-00263
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
PMA/PMN NumberP000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 07/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberESR9182400
Device Catalogue NumberESR9182400
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/24/2017 Patient Sequence Number: 1
-
-