MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING,WOUND,OCCLUSIVE

Model Number	66800269
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the single piece of the allevyn gentle border 7.5x7.5cm int is unsealed.It is unknown when the event happened or if a delay occur and if a smith and nephew backup device was available to perform the intended procedure.
Additional Manufacturer Narrative
It was reported that during set up or inspection the single piece of the allevyn gentle border 7.5x7.5cm int is unsealed.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.The device was used for treatment and was returned for analysis.The device was only sealed on 3 sides and so the dressing could not be used.We have therefore been able to confirm a relationship between the event and the device.The batch records were 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 revealed no similar instances in the last 12 months.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.Probable root cause is that the machine on which the dressing is made has stopped and the faulty dressing not removed from the line before it was started up again.There are strict checks in placed to prevent any faulty dressing proceeding through the manufacturing process.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 GENTLE BORDER 7.5X7.5CM INT
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14291283
• Report Number: 8043484-2022-00151
• Device Sequence Number: 12114500
• Product Code: NAD
• UDI-Device Identifier: 05000223463878
• UDI-Public: 05000223463878
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: 66800269
• Device Catalogue Number: 66800269
• Device Lot Number: 2132
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown