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

Model Number EN29141022

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

A titan touch pump and two cylinders were received for evaluation.Quality concluded that creasing fatigued the material over an extended period of time and most likely resulted in the noted confined abrasion and eventual separation of the cylinder # 1 exhaust tubing.A separation of this type would allow the loss of fluid, rendering the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to tubing fracture 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 06/23 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 the available information, tubing fracture.

• Brand Name: TITAN TOUCH NB SCROT ZERO 14CM
• 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: 6737974
• MDR Text Key: 80868954
• Report Number: 2125050-2017-00149
• 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: distributor
• 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: EN29141022
• Device Catalogue Number: EN29141022
• Device Lot Number: 4373029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: 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: 62 YR