MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR INFRA ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number ESR8182400

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 06/27/2017

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, fluid loss, break in tubing pump to reservoir.

• Brand Name: (2BO)TITAN OTR INFRA ZERO ANG
• 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: 7369895
• MDR Text Key: 103440130
• Report Number: 2125050-2018-00253
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487542
• UDI-Public: 05708932487542
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESR8182400
• Device Catalogue Number: ESR8182400
• Device Lot Number: 3634120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR