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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH NB SCROT ZERO 14CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH NB SCROT ZERO 14CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number EN29141022
Device Problem Migration or Expulsion of Device
Event Date 04/12/2019
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, erosion exposure to glans.

 
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Brand NameTITAN TOUCH NB SCROT ZERO 14CM
Type of DeviceINFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
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 rivier road north
minneapolis , MN 55411
6123578517
MDR Report Key8641934
Report Number2125050-2019-00409
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Type of Report Initial,Followup
Report Date 08/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberEN29141022
Device Catalogue NumberEN2914
Device LOT Number4460853
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/14/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
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: 05/24/2019 Patient Sequence Number: 1
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