MAUDE Adverse Event Report: COLOPLAST A/S FURLOW (INSERTION TOOL); SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number QB55551020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2021

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, during attempted implant of this device, the patient sustained an unspecified urethral injury and the implant was aborted.No other adverse patient effects were reported.

Manufacturer Narrative

Updated from unknown inflatable penile prosthesis to furlow insertion tool.Updated annex a, annex e, and annex f to reflect additional information.Updated to reflect physician information.

Event Description

Additional information received further reported that a distal ureteral perforation occurred with the furlow during the measuring portion of the case.It was noted that the patient had "bad tissue.".

• Brand Name: FURLOW (INSERTION TOOL)
• Type of Device: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11777845
• MDR Text Key: 249085657
• Report Number: 2125050-2021-00467
• Device Sequence Number: 1
• Product Code: KOA
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: Health Professional
• Device Model Number: QB55551020
• Device Catalogue Number: QB5555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR