MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X25CM; DRESSING,WOUND,OCCLUSIVE

Model Number	66800264
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that a allevyn gentle border 10x25cm was partially under the seam and contained a small piece of the second wound dressing.The wound dressing was therefore not sterile since it was noticed during an inspection, no patient was involved.
Additional Manufacturer Narrative
H3, h6: the device was not used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a root cause.A manufacturing process review was carried out.There are strict inspections during the manufacturing process to ensure that products that do not meet specifications are rejected.Probable causes may include human inspection failure during the packaging process.¿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.A review of complaint history did not reveal similar events for the listed batch and part number.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.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Internal complaint reference number: (b)(4).

• Brand Name: ALLEVYN GENTLE BORDER 10X25CM
• 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: 14741296
• Report Number: 8043484-2022-00175
• Device Sequence Number: 12196432
• Product Code: NAD
• UDI-Device Identifier: 05000223491833
• UDI-Public: 05000223491833
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 09/01/2024
• Device Model Number: 66800264
• Device Catalogue Number: 66800264
• Device Lot Number: 202137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 06/19/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown