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

Model Number QB55551002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

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, right distal perforation during measurement with furlow.Surgeon repaired perforation and continued with insertion of cylinders.

• Brand Name: FURLOW INSERTER NON STERILE
• Type of Device: NEEDLE GUIDE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-can[?]da, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold
• MDR Report Key: 6400744
• MDR Text Key: 69821562
• Report Number: 9610711-2017-00010
• 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: 03/13/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 52 YR