MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN STERILE 20X10CM CTN 100

Catalog Number 66974939

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that a melolin sterile 20x10cm ctn 100 package, can not be opened aseptically.No case involved.

Manufacturer Narrative

The device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual inspection reported no issues, functional assessment confirmed they were difficult to open.The root cause was identified as a glue firmness and storage environment issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances.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 a melolin sterile 20x10cm ctn 100 package, can not be opened aseptically, because the sterile part is not sufficiently integral and strong and tears when opened.No case involved.

• Brand Name: MELOLIN STERILE 20X10CM CTN 100
• Type of Device: MELOLIN STERILE 20X10CM CTN 100
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11813820
• MDR Text Key: 253215496
• Report Number: 8043484-2021-01090
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66974939
• Device Lot Number: 2032B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1