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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TITAN TOUCH; INFLATABLE PENILE PROSTHESIS
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TITAN TOUCH; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number E179262400
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
According to available information, the patient with this device experienced pending erosion and mild glans hypermobility.
 
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Brand Name
TITAN TOUCH
Common Device Name
INFLATABLE PENILE PROSTHESIS
MDR Report Key12242706
Report Number2125050-2021-00991
Device Sequence Number4137120
Product Code FHW
UDI-Device Identifier05708932322584
UDI-Public05708932322584
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/28/2021
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
Operator of Device Lay User/Patient
Device Expiration Date03/26/2022
Device Model NumberE179262400
Device Catalogue NumberE17926
Device Lot Number5637059
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/28/2021
Initial Report FDA Received Date07/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age67 YR
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