MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (LARGE) PACK OF 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801307

Device Problem Material Integrity Problem (2978)

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

Event Date 03/24/2021

Event Type  malfunction  

Event Description

It was reported that, customer has noticed allevyn life sacrum device dressings they use are leaving behind silicon beads on the dressing backing and on the patients skin when removed.It is unknown when did the event ocurred, how was the procedure completed any if there was a delay.No other complications were reported.

Manufacturer Narrative

H10: it was reported that the customer noticed allevyn life sacrum device dressings are leaving behind silicone beads on the dressing backing and on the patients skin when removed.The device used in treatment, has not been returned for evaluation.We have not been able to establish a relationship between the reported event or determine a root cause.The reported event is mitigated in the risk files with no amendments deemed necessary.As no lot number was provided it was not possible to carry out a device history review.A complaint history review on the product family revealed similar instances of the reported event with corrective actions implemented related to the reported event.A probable root cause may include a component failure, the wound contact layer within these dressing can be affected by storage temperature fluctuations as detailed in the ifu.Smith + nephew will continue to monitor for 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 number: (b)(4).

• Brand Name: ALLEVYN LIFE SACRUM (LARGE) PACK OF 10
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 11683386
• MDR Text Key: 245995283
• Report Number: 8043484-2021-00866
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1