MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66974930

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, when the brand-new melolin roll was taken out of the package, it was confirmed there were stains on the dressing, so it was not used for treatment.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was received for evaluation.At the present time we are unable to locate the sample ,with steps taken to prevent a re-occurrence.We have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include a manufacturing process issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported 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.

• Brand Name: MELOLIN NON STERILE ROLL 50CMX7M CTN 1
• 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: 11073752
• MDR Text Key: 223702933
• Report Number: 8043484-2020-04395
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223049300
• UDI-Public: 5000223049300
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66974930
• Device Lot Number: 2016B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1