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

Catalog Number 66801307

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

It was reported that the dressing ripped when they went to peel it back and assess the patient.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.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.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The retained sample was assessed and found to perform as expected.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.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting due to the dressing ruptured when it was pulled back, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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
• MDR Report Key: 8040450
• MDR Text Key: 126517297
• Report Number: 8043484-2018-00352
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 66801307
• Device Lot Number: 201818
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 10/15/2018; 10/15/2018
• Supplement Dates FDA Received: 12/28/2018; 03/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1