MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN TRACHEOSTOMY 3.5X3.5" CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number 66027640

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during treatment the patient had a severe allergic reaction to allevyn trach dressing.This adverse event was resolved by supplying epinephrine x2 and benadryl x1 and removing the dressing.Current health status of the patient is ok.

Manufacturer Narrative

Additional information: d4 (expiration date), d8, h4, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a root cause.Probable cause include incorrect skin preparation, incorrect dressing application or the patient experienced a reaction to one or more of the components of the dressing.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct skin preparation technique and dressing application.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A review of complaint history did not reveal similar events for this nature with no manufacturing problems observed.A clinical/medical assessment was performed and determined no further actions are required.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Corrected data: b1, d1, d4 (catalog number & udi), h6 (health effect - impact code).

• Brand Name: ALLEVYN TRACHEOSTOMY 3.5X3.5" CTN 10
• 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
• 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: 14153877
• MDR Text Key: 289697536
• Report Number: 8043484-2022-00123
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223415860
• UDI-Public: 05000223415860
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66027640
• Device Catalogue Number: 66027640
• Device Lot Number: 202206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 25 KG