MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. JELONET 5X5CM CTN 50; DRESSING,WOUND,OCCLUSIVE

Catalog Number 7403

Device Problems Fluid/Blood Leak (1250); Delivered as Unsterile Product (1421)

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

Event Date 02/08/2021

Event Type  malfunction  

Event Description

It was reported that the jelonet products are leaked.It is unknown when this was noticed and whether the product was used.

Manufacturer Narrative

The product is not approved in the us.Therefore, under the regulations set forth under 21 c.F.R.§803, it is concluded that this is not a reportable event to the fda.

• Brand Name: JELONET 5X5CM CTN 50
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11429743
• MDR Text Key: 238329540
• Report Number: 8043484-2021-00468
• Device Sequence Number: 1
• Product Code: NAD
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7403
• Device Lot Number: 202036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1