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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29202400
Device Problems Tube (525); Hole In Material (1293); Material Puncture/Hole (1504)
Patient Problem No Information (3190)
Event Date 03/09/2018
Event Type  Injury  
Manufacturer Narrative

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 of 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, tubing had hole.

 
Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation. The device is not available for evaluation. Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis. If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures. Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release. Management routinely reviews events such as this and monitors complaint levels. Additionally, events of this type are captured in the product risk documentation. Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 20CM
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
stephanie perryman
1601 west rivier road north
minneapolis, MN 55411
6124345685
MDR Report Key7399748
MDR Text Key104468123
Report Number2125050-2018-00271
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
PMA/PMN NumberP000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29202400
Device Catalogue NumberES29202400
Device LOT Number5860416
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/05/2018 Patient Sequence Number: 1
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