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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS
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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29142400
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 06/25/2019
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.
 
Event or Problem Description
According to the available information, the device was only a revision surgery to gain extra tubing length for this particular patient who felt the pump sat a bit high in the scrotum for his comfort.There was no fault in the existing pump or device.
 
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Brand Name
TITAN TOUCH SCRO ZERO ANG 14CM
Common Device Name
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key8818378
Report Number2125050-2019-00609
Device Sequence Number3272743
Product Code FHW
UDI-Device Identifier05708932539166
UDI-Public05708932539166
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/19/2019
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 Lay User/Patient
Device Model NumberES29142400
Device Catalogue NumberES2914
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/23/2019
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 Other;
Patient Age61 YR
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