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

Catalog Number WD66801306

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/09/2019

Event Type  Injury  

Event Description

It looks like our allevyn small sacrum dressing stared to left gel beads on the patient once the dressing was removed.Skin break down due to removing the gel beads.

Manufacturer Narrative

Correction: type of reportable event, event, and adverse event or product problem.

Event Description

It was reported that the allevyn small sacrum dressing stared to left gel beads on the patient once the dressing was removed.Skin break down due to removing the gel beads, epidermal stripping.No further harm was reported, the patient was discharged.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.No dhr/batch record review possible as no lot numbers have been made available and no complaint sample was available for assessment.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.The clinical evaluation was carried out and is attached to this report.The database of change controls for the allevyn life product family was reviewed and there were no changes to raw materials, manufacturing methods or equipment since the original qualification exercises that could have contributed to the issue experienced by the customer or alleged adverse reaction.The investigation did not find product defect or manufacturing process issue.The complaint sample was 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: 8340997
• MDR Text Key: 136246241
• Report Number: 8043484-2019-00075
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WD66801306
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1