MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 5.5X12CM; DRESSING,WOUND,OCCLUSIVE

Model Number	66800836
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Burning Sensation (4540)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the adhesive on the dressing has left a red itchy mark on patient's skin, where the adhesive around the entire circumference of the plaster had made contact with patient's skin.The plaster was applied by a nurse.Within an hour of it being applied to patient's skin, there was a burning, itching sensation and the dressing was removed.Patient's skin remains itchy and red five weeks after using the product, which is causing discomfort and distress.Patient has been receiving ongoing treatment for this allergic reaction.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The device, used in treatment, has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.As with all adhesive products, some irritation can occur during application and removal, particularly on patients with sensitive skin.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.The clinical evaluation concluded: the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to use of the reported plaster, a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Per communications, the dressing was removed, and the patient has been receiving ongoing treatment for this allergic reaction.Therefore, no further clinical/medical assessment is warranted at this time.A risk management review was carried out and the associated risk files contain the reported failure/harm or event.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.This investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER LITE 5.5X12CM
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11060197
• Report Number: 8043484-2020-04356
• Device Sequence Number: 16470594
• Product Code: NAD
• UDI-Device Identifier: 05000223475529
• UDI-Public: 05000223475529
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 66800836
• Device Catalogue Number: 66800836
• Device Lot Number: 201809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR