MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 10X10CM; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800835

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

It was reported that the allevyn gentle border lite couldn't handle a large amount of liquid so there was a leakage.The patient is incontinent for urine and it cannot be ruled out that urine has come on the outside of the allevyn gentle border lite bandage.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation, but a control sample was provided.The functional evaluation found no fault.This assessment was unable to establish a relationship between the reported event and the device.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history reviewed found only this complaint relating to absorbency, all complaints are monitored, however no further action is deemed necessary in relation to this complaint.It is noted that the initial report provided details that the patient is incontinent and urine leakage could not be ruled out.The product is designed to absorb a minimum of 18gms per 100cm2.We have been unable to determine a root cause on this occasion.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.

• Brand Name: ALLEVYN GENTLE BORDER LITE 10X10CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9718584
• MDR Text Key: 181661608
• Report Number: 8043484-2020-00102
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K063835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

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 Catalogue Number: 66800835
• Device Lot Number: 201852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1