MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADHESIVE 7.5X7.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66000043
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that one (1) allevyn adhesive 7.5x7.5cm ctn 10 dressing came open / unsealed from the box.As this happened in a non-therapeutic environment, there was not patient involvement.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection confirmed that there was a very clear lacquer transfer, which confirmed that there is no issue with the sealing process.The manufacturing process review was carried out.The pouch will be torn open for inspection during the normal process of sampling and testing, but all samples will be scrapped for disposal and will not be mixed with the normal product.There are strict checks in the subsequent packaging process.The problem of the complaint could not be confirmed in the manufacturing process.A probable cause includes being opened after shipping.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A review of complaint history did not reveal similar events for the listed batch and part number with no manufacturing problems observed.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.

• Brand Name: ALLEVYN ADHESIVE 7.5X7.5CM CTN 10
• 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: 16559143
• Report Number: 8043484-2023-00019
• Device Sequence Number: 5561028
• Product Code: NAD
• UDI-Device Identifier: 05000223411572
• UDI-Public: 5000223411572
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 08/01/2025
• Device Catalogue Number: 66000043
• Device Lot Number: 202235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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