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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 QN89161400
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Insufficient Information (4580)
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 # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Lot: 5725332.
 
Event or Problem Description
According to the available information, the device stopped working.It 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 Key12288831
Report Number2125050-2021-01097
Device Sequence Number11930204
Product Code FHW
UDI-Device Identifier05708932323604
UDI-Public05708932323604
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
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) 08/06/2021
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 NumberQN89161400
Device Catalogue NumberQN8916
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/20/2021
Initial Report FDA Received Date08/06/2021
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 Age68 YR
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