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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 ER8125
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  Injury  
Event Description
According to the available information the reservoir herniated from the retropubic space and was pressing on the patient's ureter.The old reservoir was removed and replaced in another location.
 
Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report and capa.No trends were noted for complaints and there were no non-conforming reports or capas that were confirmed to be associated.
 
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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 Key18394084
MDR Text Key331324873
Report Number2125050-2023-01646
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Reporter Country CodeUS
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 12/26/2023
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
Device Operator Lay User/Patient
Device Catalogue NumberER8125
Device Lot Number9094753_ER81252400
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/26/2023
Date Device Manufactured04/28/2023
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 Age65 YR
Patient SexMale
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