MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LEUKOCLIP SD HANDLE; TOPICAL APPROXIMATION SYSTEM

Catalog Number 66047111

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 07/23/2020

Event Type  malfunction  

Event Description

It was reported that the handles (springs) spikes drop out of devices, handles don't bend the skin staplers enough, so the doctor gets stuck with the handle at the patients head skin which causes pain.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the product is not approved in the us, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEUKOCLIP SD HANDLE
• Type of Device: TOPICAL APPROXIMATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10424398
• MDR Text Key: 203449333
• Report Number: 8043484-2020-02534
• Device Sequence Number: 1
• Product Code: MZR
• Combination Product (y/n): N
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66047111
• Device Lot Number: 887816
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1