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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS
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COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QN89181400
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Serious Injury
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 supplemental reports, a follow-up report will be submitted.The lot number was reviewed for complaint trend, nonconforming report and capa.Lot: 0935784.
 
Event or Problem Description
According to the available information, a tubing leak was noted on the cylinder to pump tubing.The device was explanted and replaced.
 
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Brand Name
TITAN
Common Device Name
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key12337439
Report Number2125050-2021-01160
Device Sequence Number4712563
Product Code FHW
UDI-Device Identifier05708932323901
UDI-Public05708932323901
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/17/2021
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 Model NumberQN89181400
Device Catalogue NumberQN8918
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/05/2021
Initial Report FDA Received Date08/18/2021
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 Required Intervention;
Patient Age65 YR
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