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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 ESR918
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2023
Event Type  Injury  
Event Description
According to available information, this device required replacement due to migration.The cylinder was no longer in the glans.No other adverse patient effects were reported.
 
Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and no trends were noted.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.
 
Manufacturer Narrative
The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of cylinder no longer in glands, quality accepts the physician¿s observations of such as the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
Event Description
According to the available information the titan otr was revised because the cylinder no longer in glands.
 
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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 Key17438629
MDR Text Key320198983
Report Number2125050-2023-00907
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,Followup
Report Date 11/03/2023
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 Expiration Date03/31/2017
Device Catalogue NumberESR918
Device Lot Number3641799_ESR9182400
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/01/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/03/2023
Date Device Manufactured04/08/2013
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 Age66 YR
Patient SexMale
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