MAUDE Adverse Event Report: COLOPLAST A/S FURLOW INSERTER NON STERILE; NEEDLE GUIDE

Model Number QB55551002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hematoma (1884)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, furlow needle was passing on the side and furlow did not fulfill its role as a pusher.They have tried many times to achieve the goals, 1h30 intervention more than planned and more exposure of the prosthesis on the operative field, the glans trauma, to date the patient has a hematoma of the glans - hematoma is resorbing,.

• Brand Name: FURLOW INSERTER NON STERILE
• Type of Device: NEEDLE GUIDE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 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: 5342129
• MDR Text Key: 35349286
• Report Number: 2125050-2015-00126
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 01/04/2016

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: Physician
• Device Model Number: QB55551002
• Device Catalogue Number: QB55551002
• Device Lot Number: 4199446
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other