MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66974930

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that before use, it was confirmed there was a foreign substance that seems to be a fiber or hair between the melolin film and the cotton layer, so the part was not used.A backup was available.No delay was reported.The sample will be returned for investigation.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 intended to be used in treatment has been returned and evaluated with photos and other information has been reviewed establishing a relationship with the reported event.Visual inspection of the returned sample confirms foreign substance is present between the melolin film.Root cause is a manufacturing process error.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains no 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.

• Brand Name: MELOLIN NON STERILE ROLL 50CMX7M CTN 1
• 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
• MDR Report Key: 11286971
• MDR Text Key: 230537001
• Report Number: 8043484-2021-00278
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223049300
• UDI-Public: 5000223049300
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: 66974930
• Device Lot Number: 2025B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1