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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROTAL 18CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (2BO)TITAN OTR SCROTAL 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QSR9181400
Device Problems Tube (525); Fluid Leak (1250); Leak/Splash (1354)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 01/25/2018
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, titan otr was explanted due to tubing leak near pump insertion.

 
Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device. An otr pump and tubing connecter were received for evaluation. Examination and testing of the returned components revealed a separation of the exhaust tubing of the pump near the strain relief of the pump. Testing revealed this to be a site of leakage. The separation appeared to be rough and irregular, indicating sufficient stress was exerted to separate the site. Surface abrasion is noted on all tubes and all strain relief of the pump. No functional abnormalities are noted with the connector. Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the exhaust tubing of the pump near the strain relief to separate the site while in-vivo. A separation of this type would then allow the loss of fluid, making the device inoperable. 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 no further corrective action is required at this time.

 
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Brand Name(2BO)TITAN OTR SCROTAL 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 river road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west rivier road north
minneapolis, MN 55411
6124345685
MDR Report Key7381804
MDR Text Key103832475
Report Number2125050-2018-00263
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQSR9181400
Device Catalogue NumberQSR9181400
Device LOT Number2472231
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2018
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

Patient TREATMENT DATA
Date Received: 03/29/2018 Patient Sequence Number: 1
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