• 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 TITAN TOUCH SCRO ZERO ANG 22CM 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 TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29222400
Device Problem Migration or Expulsion of Device
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative

No product was received for evaluation. As examination of the components may not conclusively confirm or disprove the report of pain, migration, and scarring, quality accepts the physician's observations as to the reason for surgical intervention. A review of the device history record confirmed the devices from this lot met all specifications prior to release. A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

 
Event Description

According to the available information, pump appeared to be working fine. The patient was having major complaints of pain when inflating the pump in the testicular region. It appeared that the pump migrated higher than the physician liked. The patient did have a significant amount of scar tissue built up around the pump.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTITAN TOUCH SCRO ZERO ANG 22CM
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
sarah o'gara
1601 west river road north
minneapolis , MN 55411
6123578517
MDR Report Key9241431
Report Number2125050-2019-00929
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 10/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29222400
Device Catalogue NumberES2922
Device LOT Number6293589
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
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 Unkown

-
-