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

Catalog Number 66801307

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  Injury  

Event Description

It was reported that the moisture build up under allevyn life when used prophylactically on the sacrum.The nurse did not have a specific event, she just mentioned seeing the issue along with her colleague at the main hospital.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A clinical assessment was carried out.It was concluded: ¿the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.¿ as no samples were provided, a product evaluation could not be carried out.No images were provided of the reported maceration, the failure mode could not be confirmed and used in the clinical assessment.A risk management review found that maceration is captured in the risk files for this product.As stated in the ifu, the appropriate dressing size should be selected to ensure the pad covers the entire wound area.Prior to application the application site should be cleansed dry and free from excess hair.On this occasion we do not have sufficient information to determine a root cause.Should more information become available, this case may be reopened.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.

Event Description

It was reported that the moisture build up under allevyn life when used over existing wounds on the sacrum.The maceration is not believed to be an incontinence issue.There is no maceration found with other allevyn life dressings on other parts of the body, only the sacrum.It sounds as though the exudate wasn¿t getting into the lock away layer but is possible the dressing is becoming saturated.Use of the dressing was certainly discontinued when the periwound maceration was found and a barrier cream used instead.The nurse did not have a specific event, she just mentioned seeing the issue along with her colleague at the main hospital.

• 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 ; UK
• MDR Report Key: 8881752
• MDR Text Key: 154125262
• Report Number: 8043484-2019-00564
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801307
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other