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

Catalog Number 66801307

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Skin Tears (2516)

Event Date 12/06/2018

Event Type  Death  

Event Description

It was reported that a patient received a skin tear, upon removing the silicone adhesive dressing.The health care professional stated that the product was used as a precaution against sacral pressure ulcer formation and that the skin tear did not seem infected.The patient was septic and in multiple organ failure prior to the application of the dressing.Smith and nephew was informed that the patient died due to complications related to multiple organ failure.

Manufacturer Narrative

We have now concluded our investigation into this complaint.No dhr/batch record review possible as no lot numbers have been made available and no sample was received for evaluation.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.A clinical evaluation was carried out and additional information was obtained from the healthcare provider who stated that the patient was in organ failure and septic throughout the body prior to the application of allevyn life sacrum.The dressing was not being used to treat a wound, but rather it was applied to the sacral area as prevention.She also stated that the dressing did not cause or contribute to the demise of the patient.No further medical assessment is warranted based on the information provided.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 (LARGE) 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 8228620
• MDR Text Key: 132428754
• Report Number: 8043484-2019-00024
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801307
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death