MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Model Number 66024007

Device Problem Difficult to Remove (1528)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, it was difficult to use the iv3000 as they stick to his site when trying to remove dressing.Procedure was completed with other adhesive bandages.

Manufacturer Narrative

We have now concluded our investigation into the reported complaint.No lot number was provided, so it was not possible to carry out a device history review for this case.A complaint history review, was performed for the product and event description, there have not been any similar instances reported in the past three years.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.We have not been able to establish a relationship between the reported event and the device.It has not been possible to establish the root cause of the issue.It was reported that the iv3000 was difficult to use as it was sticking to the skin when trying to remove it.Probable root causes include incorrect application or removal of the dressing or incorrect storage prior to use.Environmental factors such as temperature can alter the adhesive nature of the dressing and so the device must be stored as per the conditions detailed in the ifu.The users of the reported product are therefore advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings and the correct conditions in which the device should be stored.Since no patient injuries are being reported no further clinical/medical assessment or risk management review is warranted at this time.The investigation has been closed.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11077693
• MDR Text Key: 223784584
• Report Number: 8043484-2020-04400
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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: 66024007
• Device Catalogue Number: 4007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention