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

Model Number QSR9221400

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

A titan otr pump, two cylinders, and reservoir were received for evaluation.Examination and testing of the returned components revealed a separation at the strain relief of the shorter exhaust tube of the pump.Quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the strain relief of the shorter exhaust tube of the pump to separate the site while in-vivo.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.(b)(4).Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.

Event Description

According to the available information, tubing break by pump.

• Brand Name: (2BO)TITAN OTR SCROTAL 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: 6739070
• MDR Text Key: 80866313
• Report Number: 2125050-2017-00253
• 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
• Type of Report: Initial
• Report Date: 07/21/2017

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: QSR9221400
• Device Catalogue Number: QSR9221400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2017
• 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: 73 YR