MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN SCROTAL RESIST 22CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89221000

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/13/2017

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 the available information, a malfunction occurred and broken tubing.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation on the top to the pump bulb.Testing revealed this to be a site of leakage.The detachment site of the shorter exhaust tube of the pump and of the exhaust tube of cylinder #2 appear to be rough and irregular.Quality concluded that the rough and irregular surfaces associated with these detachment sites indicate that sufficient stress(s) may have been exerted on the exhaust tube of cylinder #2 and the non-serialized exhaust tube of the pump.The rough and irregular surfaces associated with the separation on the top of the pump bulb indicates sufficient stress may also have been exerted to separate the site while in-vivo.Separations of this type could then allow the loss of fluid, making the device inoperable.However, as additional information was not received, quality is unable to determine if only one or both sites were the cause for the reported failure.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 SCROTAL RESIST 22CM
• 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: 6807001
• MDR Text Key: 83124653
• Report Number: 2125050-2017-00361
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89221000
• Device Catalogue Number: QS89221000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• 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: 74 YR