MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66801304
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Sections h6 (type of investigation and investigation findings) and h11 were updated.H11: results of investigation: the product was not returned for evaluation; however, the provided images were reviewed and revealed that the packaging was not intact, was already opened.The review of the production records showed no manufacturing issues that could have contributed to the reported incident.No similar events were found in the complaint history; therefore, this would suggest it is an isolated event.A historical review concluded that there have been no previous escalated actions for the part number and failure mode reported.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Additionally, product prints stated that the dressing pouches shall be 100% visually inspected.The photos provided showed that the pouch film was already peeled open, and we cannot confirm the original status of the pouch seal.All the dressing pouches are visually inspected during manufacturing.The probable root cause may include that the pouch was peeled open in the distribution chain or with the end user.There were no manufacturing, design or labeling deficiencies identified which would have contributed to the complaint.No escalation is required.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that the allevyn life heel (global) pack of 5 packaging was not intact and was found in a torn condition.As this was noticed in a non-therapeutic environment, there was not patient involved.
Additional Manufacturer Narrative
Internal complaint referece: device returned for evaluation.Sections d9, h3, h6 and h11 were updated.H3, h6: results of investigation: the product/packaging was returned for evaluation.The visual inspection performed on the returned product revealed that the dressing pouch was opened.The provided images were reviewed and revealed the same issue.The review of the production records revealed no issues were detected during the manufacturing process.No similar events were found in the complaint history; therefore, this would suggest it is an isolated event.A historical review concluded that there have been no previous escalated actions for the part number and failure mode reported.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Additionally, product prints stated that the dressing pouches shall be 100% visually inspected.The returned dressing pouch was in open status.The 3 sides of the pouch had no sealing lacquer transfer.Only one side of the pouch had a trace of lacquer transfer.The root cause is a quality inspection failure, the open pouch was not removed during inspection.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.However, based on this investigation, the need for corrective action is not indicated.

• Brand Name: ALLEVYN LIFE HEEL (GLOBAL) PACK OF 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23265826
• Report Number: 8043484-2025-00094
• Device Sequence Number: 15991263
• Product Code: NAD
• UDI-Device Identifier: 05000223482510
• UDI-Public: 5000223482510
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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 Catalogue Number: 66801304
• Device Lot Number: 202440
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 04/23/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/11/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2024
• 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