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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29162400
Device Problem Migration or Expulsion of Device
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review. No trends were noted. The device has been received at coloplast; however the evaluation is not yet complete. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Once our evaluation is complete, a follow-up report will be submitted.

 
Event Description

According to the available information, the penile prosthesis was explanted due to malfunction. Wound erosion and exposure of implant were reported. The device was damaged (tubing at pump) to facilitate explant. The implant was replaced with another device.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 16CM
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 river road north
minneapolis MN 55411
Manufacturer Contact
lauren prioleau
1601 west river road north
minneapolis , MN 55411
6122196218
MDR Report Key9497741
Report Number2125050-2019-01159
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29162400
Device Catalogue NumberES2916
Device LOT Number4684247
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
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: 12/19/2019 Patient Sequence Number: 1
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