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	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the allevyn life heel dressings from lot number 202127 shows a bubble in the packaging, so sterility is no longer assured.As this was noticed upon inspection, the patient was not involved at that moment.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
The device 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 and the device or determine a root cause.It was reported that the allevyn life heel dressings shows a bubble in the packaging, it was confirmed with customers the bubble was between wcl and pink film.A review of the manufacturing process did not found any deficiencies.All the dressings are inspected by the on-line appearance inspection as per the in-process control specification.Any dressing out of specifications will be manually removed.Probable causes may include customer expectation dressing¿s appearance was higher than specification.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 review of complaint history did not reveal similar events for this nature with no manufacturing problems observed.The risk files mitigate the reported issue 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.

• 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: 13502220
• Report Number: 8043484-2022-00064
• Device Sequence Number: 5387425
• Product Code: NAD
• UDI-Device Identifier: 05000223482503
• UDI-Public: 05000223482503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 07/01/2024
• Device Model Number: 66021304
• Device Catalogue Number: 66801304
• Device Lot Number: 202127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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