MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROTAL 16CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9161400

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

A pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a rough and irregular separation, indicating sufficient stress(s) had been exerted to separate the site, through the serialized strain relief of the pump.The pump exhaust tubes and inlet tube were overlapping each other while in-vivo.This positioning, in combination with device usage over time, could then cause sufficient stress resulting in the eventual separation of the serialized strain relief of the pump.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 relating to crack in tubing by pump are captured in the product risk documentation and are addressed in the literature that accompanies the device.Based on this, no further corrective action is required at this time.  see attached letter from fda dated (b)(6) indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(4) program.Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.

Event Description

According to available information, crack in tubing by pump.

• Brand Name: (2BO)TITAN OTR SCROTAL 16CM
• 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: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6737904
• MDR Text Key: 80865699
• Report Number: 2125050-2017-00157
• 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
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QSR9161400
• Device Catalogue Number: QSR9161400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 46 YR