MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN JELONET; DRESSING,WOUND,OCCLUSIVE

Catalog Number UNKN05004000

Device Problems Loss of or Failure to Bond (1068); Material Disintegration (1177)

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

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that, during burn treatment with a combination of an unknown cuticerin dressing and an unknown jelonet dressing, there were residues from these dressings that adhered to the wound.Patient also reported that dressings kept loosening and did not provide irritation relief in the wound area.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

Manufacturer Narrative

H3, h6: the device, used in treatment was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.Probable root cause may include application, and or product failure.No batch/lot number has been provided; therefore, a review of the device history has not been possible.A complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that, during burn treatment with an unknown cuticerin dressing, there were residues from these dressings that adhered to the wound.Patient also reported that dressings kept loosening and did not provide irritation relief in the wound area.As this was noticed in a retrospective post market clinical follow up activity, further information is not available.

Manufacturer Narrative

H11: the information received by the manufacturer has been re-evaluated.During the initial assessment of the information available, there was confusion regarding the post market clinical follow up study that contained the present adverse: it was assumed from the study's title that the clinical study referred to 2 (two) different dressings (cuticerin and jelonet), nevertheless, after further review from our post market surveillance team it has been revealed that the scope of the post market clinical follow up study was limited to only 1 (one) dressing: cuticerin, therefore this adverse event reported for jelonet is not valid.

• Brand Name: UNKN JELONET
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11881034
• MDR Text Key: 252934463
• Report Number: 8043484-2021-01202
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2023

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: UNKN05004000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 10/05/2021; 01/05/2023
• Supplement Dates FDA Received: 10/05/2021; 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1