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

Model Number QB55551002

Device Problems Component Falling (1105); Material Frayed (1262)

Patient Problems No Information (3190); No Code Available (3191)

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, when using the keith needle on the dacron pull suture - when you deploy it through the glans the dacron suture is frayed and fall to bits.This means you cannot locate the implant in the shaft.There appears to be no clinical consequences.The operation time was excessive, but coloplast has not been alerted to any infection or impaired function.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A search was completed for other complaints, and there were no other complaints found for this lot number.Visual examination of the returned device revealed clean edges without noticable burs.The device was reviewed following the instructions for use, and the device operated smoothly and did not result in damage to the suture.A lot review was completed, which didn't reveal any recorded anomaly in connection with the described event.Based on the above, this complaint is not confirmed as a product defect.

• 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; 9 avenue edmond rostand; sarlat-la-caneda, 24206 ; FR 24206
• Manufacturer Contact: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 7361404
• MDR Text Key: 103161215
• Report Number: 9610711-2018-00006
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: Physician
• Device Model Number: QB55551002
• Device Catalogue Number: QB55551002
• Device Lot Number: 6009375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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