MAUDE Adverse Event Report: COLOPLAST A/S (OUT)TITAN SCROTAL RESIST 18CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89181000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

A titan pump, two cylinders and lockout reservoir were received for evaluation.Examination and testing of the returned components revealed a separation through the serialized strain relief tube.Testing revealed this to be a site of leakage.Quality concluded that the rough and irregular surface associated with this separation indicates sufficient stress(s) was exerted 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 relating to tubing break 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.(b)(4).

Event Description

According to the available information, clear tubing break.

• Brand Name: (OUT)TITAN SCROTAL RESIST 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: 6740816
• MDR Text Key: 80935082
• Report Number: 2125050-2017-00209
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89181000
• Device Catalogue Number: QS89181000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• 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