• 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 NB SCROT ZERO 14CM; 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 NB SCROT ZERO 14CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number EN29141022
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Erosion (1750)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.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 or 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, erosion exposure to glans.
 
Manufacturer Narrative
This follow-up mdr is created to document the returned device updated codes.As examination of the device may not conclusively confirm or disprove the report of erosion.Quality accepts the physician's observations as to the reason for surgical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TITAN TOUCH NB SCROT ZERO 14CM
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
3050
DA  3050
MDR Report Key8641934
MDR Text Key146112657
Report Number2125050-2019-00409
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 08/29/2019
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 NumberEN29141022
Device Catalogue NumberEN2914
Device Lot Number4460853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Initial Date Manufacturer Received 04/25/2019
Initial Date FDA Received05/24/2019
Supplement Dates Manufacturer Received04/25/2019
Supplement Dates FDA Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
-
-