MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE XL 21X21 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number	66801070
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the dressing was used to prevent skin troubles during 13 hours brain surgery in park bench position, when the product was removed from the skin, it was confirmed the patient had gotten a contact dermatitis.This adverse event was treated by steroid therapy (rinderon and petroleum jelly) by a dermatologist.The patient is in the healing tendency.
Additional Manufacturer Narrative
H3, h6: it was reported that, the dressing was used to prevent skin troubles during 13 hours brain surgery in park bench position, when the product was removed from the skin, it was confirmed the patient had gotten a contact dermatitis.This adverse event was treated by steroid therapy (rinderon and petroleum jelly) by a dermatologist.The patient is in the healing tendency.The device was not returned for analysis.We have therefore not been able to confirm a relationship between the event and the device, or identify a definitive root cause.A lot number for the device was not provided, therefore it was not possible to carry out a device history review.A complaint history review (chr) revealed a small number of similar instances in the last 12 months.There is nothing to indicate this is outside of acceptable rates of occurrence.A clinical/medical review was conducted.This review concluded that the use of allevyn¿ life as part of a prophylactic pressure ulcer prevention therapy, does not preclude the need to continue to develop and follow a comprehensive pressure ulcer prevention protocol (e.G., regular turning, appropriate mattress and skin care)¿.Therefore, it cannot be concluded that the reported adverse event was associated with a mal performance of the device.As it was reported the patient is in the 'healing tendency', no further clinical/medical assessment is warranted at this time.A risk management review (rmr) was conducted and which mitigated the reported issue with no further action or updates required.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.A review concluded that there are no prior escalated actions related to this product and the reported event.The probable root cause for this complaint is patient skin sensitivity; that the patient's skin was sensitive to one or more of the components of the dressing.Inadequate skin preparation and/or existing skin condition(s) could also be a cause or a contributing factor to the reported event.The users of the reported product are advised to consult the relevant ifu, to prevent future occurrences of the reported issue.This guide will provide comprehensive instructions of the operation, use and limitations of the device, including skin preparation and care when sensitive skin is an issue.Investigations into this matter are now complete and no further actions by smith & nephew are 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 LIFE XL 21X21 CTN10
• Common Device Name: 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: 15492224
• Report Number: 8043484-2022-00185
• Device Sequence Number: 19312359
• Product Code: NAD
• UDI-Device Identifier: 05000223478070
• UDI-Public: 05000223478070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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
• Device Model Number: 66801070
• Device Catalogue Number: 66801070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STEROID THERAPY (RINDERON AND PETROLEUM JELLY) BY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 86 KG