MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE 10X10CM CTN 150; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66974942

Device Problem Contamination (1120)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).Postal code: (b)(6).

Event Description

It was reported that, before wound treatment, it was confirmed that there was a stain or foreign substance on a melolin low-adherent absorbent dressing.Treatment was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device has been returned for evaluation, confirming the reported event.A visual inspection, confirmed the presence of a dark stain on the corner of the pad.A documentation review has been conducted, complaint history records have been reviewed and updated; the review has observed a previous manufacturing quality issue, historical data shows no previous escalations.No lot number was supplied.The product risk files require no updates, adequate mitigation is in place.The instruction for use has been reviewed and contain no contributory factors that could influence the reported event.The probable root cause for the reported event has been established as a manufacturing quality problem.Quality actions have taken place regarding similar events to prevent further reoccurrences.Without a valid lot, serial number we cannot perform any additional investigations, but we will continue to monitor for adverse trends relating to this product range.Smith & nephew continue to control the release of batches/devices against manufacturing specifications as part of our approved quality management system.

• Brand Name: MELOLIN NON STERILE 10X10CM CTN 150
• 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
• 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: 12682938
• MDR Text Key: 278102576
• Report Number: 8043484-2021-01910
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223049423
• UDI-Public: 5000223049423
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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: 66974942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/11/2022
• 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: Initial
• Patient Sequence Number: 1