MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADHESIVE 12.5X12.5CM CTN 10 DRESSING,WOUND,OCCLUSIVE

Catalog Number 66020044

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.

• Brand Name: ALLEVYN ADHESIVE 12.5X12.5CM 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: 14153911
• Report Number: 8043484-2022-00124
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223438395
• UDI-Public: 5000223438395
• 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?: No

Device Operator

• Device Catalogue Number: 66020044
• Device Lot Number: 202144
• 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: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Outcome(s): Required Intervention