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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number 5177502400
Device Problem Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
According to available information, this device required replacement due to positioning.The pump was replaced and repositioned.No other adverse patient effects were reported.
 
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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
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Brand Name
TITAN TOUCH
Type of Device
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usbes brian e schmidt
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key15284078
MDR Text Key298496917
Report Number2125050-2022-00815
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932533966
UDI-Public05708932533966
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/24/2022
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? Yes
Device Operator Lay User/Patient
Device Model Number5177502400
Device Catalogue Number517750
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2022
Initial Date FDA Received08/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient SexMale
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