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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES28182400
Device Problem Free or Unrestricted Flow
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report 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, the patient reported auto inflation issues to the physician. The surgeon was not able to verify the auto inflation. Possible infection was also reported, however no cultures were taken to confirm. The inflatable device was removed and replaced with another inflatable device.

 
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Brand NameTITAN TOUCH INFR ZERO ANG 18CM
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
stephanie perryman
1601 west rivier road north
minneapolis , MN 55411
6124345685
MDR Report Key9210384
Report Number2125050-2019-00876
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 10/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES28182400
Device Catalogue NumberES2818
Device LOT Number5988752
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 10/18/2019 Patient Sequence Number: 1
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