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

Catalog Number 66974930

Device Problem Contamination (1120)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during set up, it was noticed that the melolin non sterile roll had a few hair-like foreign substances.Procedure was completed, without any delay, using a back-up device.There was no patient involvement.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.Without verifying the reported contamination and or batch/lot number the complaint cannot be confirmed.In addition the manufacturing records cannot be reviewed.Complaint history records shows previous cases of a similar nature.Following process reviews, manufacturing quality concerns have been identified.Corrective action has been implemented to reduce the probability of future occurrences.Product risk files adequality mitigate the reported event type, with no updates required.Potential causes include manufacturing missed quality checks.No additional actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.

• 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
• 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: 13716077
• MDR Text Key: 286922569
• Report Number: 8043484-2022-00098
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223049300
• UDI-Public: 5000223049300
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66974930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2022
• 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