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 Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

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 available information, tubing fracture.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device, and the additional lot number and patient information received.A titan touch pump, two cylinders, and a pieced of detached inlet connector tubing were received for evaluation.Examination and testing of the returned components revealed a separation in the detached inlet tubing near the connector.Testing revealed this to be a site of leakage.The separation appears to be smooth and straight, indicating contact with sharp instrumentation.Surface abrasion is noted on all tubes and all strain relief of the pump.No functional abnormalities are noted with the pump, cylinder #1, or cylinder #2.Based on quality's examination, quality concluded that the observed separation in the detached inlet tubing would have allowed the reported "tubing fracture".However, because the limited information provided does not indicate any factors that may have contributed to the reported event, quality cannot confirm when the observed separation occurred.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.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: 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: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7270086
• MDR Text Key: 100053681
• Report Number: 2125050-2018-00161
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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: 4487893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• 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: 55 YR