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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

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COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE Back to Search Results
Catalog Number EN2918
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 01/25/2024
Event Type  Injury  
Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified in veeva.
 
Event Description
According to the available information the device was removed due to infection and was not replaced.
 
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Brand Name
TITAN INFLATABLE PENILE PROSTHESIS FAMILY
Type of Device
PENILE PROSTHESIS, INFLATABLE
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18987155
MDR Text Key338718569
Report Number2125050-2024-00491
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932539180
UDI-Public05708932539180
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
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
Device Operator Lay User/Patient
Device Catalogue NumberEN2918
Device Lot Number7051004_EN29181022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/27/2024
Date Device Manufactured10/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
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