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

Model Number 66800264

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 294508444
• Report Number: 8043484-2022-00175
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223491833
• UDI-Public: 05000223491833
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1