MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN IV3000; TAPE AND BANDAGE, ADHESIVE

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Event Description

It was reported that the product do not stick properly.No patient harm was reported.

Manufacturer Narrative

Tegaderm is not a smith and nephew product it is neither manufactured or distributed by smith & nephew, this is a 3m product and therefore cannot be investigated by s&n.On this occasion we have not been able to identify a definitive root cause for the device as reasonable effort to obtain a lot number and confirmation of the device used have not been successful.Should the lot number become available at a later date and it is confirmed that this issue is related to a s&n device then this complaint may be re-opened.Smith and nephew are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKNOWN IV3000
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8206543
• MDR Text Key: 131724690
• Report Number: 8043484-2018-00474
• Device Sequence Number: 1
• Product Code: KGX
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1