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

Catalog Number 66801306

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Skin Tears (2516)

Event Date 01/23/2019

Event Type  Injury  

Event Description

It was reported that a patient developed a skin tear on the sacral area during the use of the allevyn life sacral.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch records were 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 its finished product specification.There was no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.No complaint sample was available for assessment but a review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The database of change controls was reviewed and found there was no raw material, methods of manufacture or manufacturing equipment changed since the original qualification exercises that could have caused or contributed to the issue experienced by the customer or alleged adverse reactions.A clinical evaluation was carried out and the findings are attached to this report.The investigation did not find product defect or manufacturing process issue.The complaint sample and product lot were not available at this time.Once the sample received, an assessment will take place to make further investigation.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN LIFE SACRUM (SMALL) PACK OF 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8355622
• MDR Text Key: 136714771
• Report Number: 8043484-2019-00121
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801306
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other