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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 ES88142400
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Pain (1994)
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 prior supplemental reports, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event or Problem Description
As reported to coloplast, though not verified, pain from pump.No other adverse patient effects were reported.
 
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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 Key12739797
Report Number2125050-2021-01591
Device Sequence Number16503871
Product Code FHW
UDI-Device Identifier05708932487160
UDI-Public05708932487160
Combination Product (Y/N)N
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/02/2021
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? No
Operator of Device Health Professional
Device Model NumberES88142400
Device Catalogue NumberES8814
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/19/2021
Initial Report FDA Received Date11/02/2021
Patient Sequence Number1
Patient Age70 YR
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