• 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 OTR SCROTAL 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 OTR SCROTAL 22CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QSR9221022
Device Problems Material Erosion (1214); Leak/Splash (1354); Pumping Problem (3016)
Patient Problem No Information (3190)
Event Date 07/01/2019
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.Once our evaluation is complete, a follow-up report will be submitted.
 
Event Description
According to the available information, the pump did not work, tubing eroded and there was fluid loss.Another pump was implanted.
 
Event Description
Additional information received indicated that the patient recalled that prior to the complete failure of the pump, several weeks before, the pump was harder to activate than usual.This was unable to be verified by the physician as the patient had already presented with the system not functioning.
 
Manufacturer Narrative
The follow-up was created to document the additional information recieved.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TITAN OTR SCROTAL 22CM
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key9417953
MDR Text Key169285830
Report Number2125050-2019-01110
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 company representative,foreig
Type of Report Initial,Followup
Report Date 02/03/2020
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 NumberQSR9221022
Device Catalogue NumberQSR922
Device Lot Number1813256
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received12/05/2019
Supplement Dates Manufacturer Received07/15/2019
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
-
-