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

Model Number	66021304
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the pouch of a allevyn life heel 25cm x 25.2cm pack was not securely sealed because a cut-off piece of extra dressing has been trapped in the sealing part.As this was noticed at the sales office, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: it was reported that the dressing pouch seal was compromised by a piece of another dressing being caught in the seal at the edge of the pouch.The device intended for use in treatment was returned for evaluation and was found to be as described in the complaint thus confirming a relationship between the event and the device.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.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review found no similar instances of the reported event.The reported event is mitigated within the risk files.A probable root cause in this case is a missed quality check.Smith and nephew have strict quality checks in place to ensure that all of their products are in perfect conditions when they leave manufacture.The investigation is now closed 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.Internal complaint reference: (b)(4).

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12899750
• Report Number: 8043484-2021-01986
• Device Sequence Number: 14443378
• Product Code: NAD
• UDI-Device Identifier: 05000223482503
• UDI-Public: 05000223482503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 09/01/2023
• Device Model Number: 66021304
• Device Catalogue Number: 66801304
• Device Lot Number: 2039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown