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

Model Number QSR9181400

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/02/2017

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 the available information, there was a break in the tubing near the pump.

Manufacturer Narrative

A titan otr pump, two cylinders, and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation at the strain relief of the inlet tube of the pump.Testing revealed this to be a site of leakage.No functional abnormalities are noted with the reservoir, cylinder #1, or cylinder #2.Quality concluded that while in-vivo both the exhaust tubes and inlet tube of the pump positioned themselves in such a way that caused them to overlap and abrade against one another.Quality further concluded that this positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the inlet tube of the pump at this site.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: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6796771
• MDR Text Key: 82772011
• Report Number: 2125050-2017-00355
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• 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: 43 YR