MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN STERILE 20X10CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66974939

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during set up for treatment, it was confirmed there was a foreign substance in the pad of a melolin sterile 20x10cm ctn 100.It was found in 2 dressings in the carton.Treatment was performed, with a back-up device instead.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device was returned for evaluation, confirming the reported event.Visual examination of the returned product confirmed the presence of the back marks, with the root cause established as a quality related issue.A documentation review has been conducted, confirming previous complaints of this nature, relating to a manufacturing quality problem, no historical escalations have been observed.A review of the device history confirmed that the product was released according to specification.A process review was conducted, with corrective action implemented to reduce the probability of further reoccurrences.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete with no additional actions deemed necessary at this stage.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.H5.

• Brand Name: MELOLIN STERILE 20X10CM CTN 100
• 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: 12972123
• MDR Text Key: 283945119
• Report Number: 8043484-2021-02007
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 2127B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• 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