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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29222400
Device Problems Loose or Intermittent Connection; Pumping Problem
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review. 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.

 
Event Description

According to the available information, true connects not secured. Additional information received stated pump failed, it would not refill after initial squeeze. True connects were disconnected at the time of exploration. Old bloody fluid observed in the reservoir and cylinders led to explantation and replacement.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 22CM
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 river road north
minneapolis, mn , MN 55411
6123578517
MDR Report Key9467966
Report Number2125050-2019-01134
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 02/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29222400
Device Catalogue NumberES2922
Device LOT Number6741645
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated By Manufacturer? Yes
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: 12/13/2019 Patient Sequence Number: 1
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