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

Model Number QSR9181400

Device Problems Fluid/Blood 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.

• Brand Name: (2BO)TITAN OTR SCROTAL 18CM
• Type of Device: INFLATABLE 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 Key: 7381804
• MDR Text Key: 103832475
• Report Number: 2125050-2018-00263
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• 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 Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9181400
• Device Catalogue Number: QSR9181400
• Device Lot Number: 2472231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR