MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. JELONET 10X10CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Catalog Number 7404

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, a jelonet 10x10cm dressing had a redish tinge which looked like blood.Incident occurred during set up/ inspection.The procedure was completed with a delay less than or equal to 30 min, using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device intended to be used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history file contains further instances of the reported event.Factors that are known to contribute to the alleged fault/failure may be related to raw material gauze.Smith and nephew will continue to monitor for any adverse trends relating to this product range.No further investigation is required.

• Brand Name: JELONET 10X10CM CTN 10
• 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: 11030901
• MDR Text Key: 222273267
• Report Number: 8043484-2020-04310
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223074043
• UDI-Public: 5000223074043
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7404
• Device Lot Number: 201937
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1