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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN ZERO ANG CYLINDER 24CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN ZERO ANG CYLINDER 24CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number E179242400
Device Problems Migration or Expulsion of Device ; Migration
Event Date 08/09/2019
Event Type  Injury  
Manufacturer Narrative

A review of the complaint history database revealed no trends for this lot. Review of nonconforming reports revealed no nonconformances for this lot. No capas are associated with this lot. 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 Description

According to the available information, left cylinder was explanted due to it migrating to the scrotum.

 
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Brand NameTITAN ZERO ANG CYLINDER 24CM
Type of DeviceINFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis , MN 55411
6123578517
MDR Report Key9045561
Report Number2125050-2019-00776
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberE179242400
Device Catalogue NumberE17924
Device LOT Number6778971
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/13/2019 Patient Sequence Number: 1
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