MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN THIN 10X10CM CTN 5; DRESSING,WOUND,OCCLUSIVE

Model Number	66047578
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Skin Disorders (4543)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, patient was admitted to the hospital because of a left hip trauma and pain with movement disorder.In order to protect the patient's bottom skin, allevyn thin 10x10cm ctn 5 was used.When the patient changed his position, the dressing was curled, causing the right buttocks skin 3cm*4cm avulsion.After disinfecting the wound, vaseline gauze was used, and then the patient required to be discharged.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: 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 complaint history review on the product family revealed a small number of similar instances in the last three years.There is nothing to indicate that this is outside acceptable rates of occurrence.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that, patient was admitted to the hospital because of a left hip trauma and pain with movement disorder.In order to protect the patient's bottom skin, allevyn thin 10x10cm was used.When the patient changed his position, the dressing was curled, causing the right buttocks skin 3cm*4cm avulsion.(skin pulling away) a clinical assessment determined that the information provided is insufficient to determine whether the patient¿s signs, symptoms, or outcome are due to 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.The instructions for use and risk files, mitigate the reported issue with no updates required.Probable root cause is incorrect application of dressing or incorrect skin preparation prior to use.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 application and removal of dressings and skin preparation prior to use.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN THIN 10X10CM CTN 5
• 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: 13176168
• Report Number: 8043484-2022-00018
• Device Sequence Number: 14608619
• Product Code: NAD
• UDI-Device Identifier: 05000223452919
• UDI-Public: 05000223452919
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 66047578
• Device Catalogue Number: 66047578
• Device Lot Number: 2023
• 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: 12/18/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female