MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 15CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000375

Device Problem Defective Device (2588)

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

Event Date 05/14/2020

Event Type  malfunction  

Event Description

It was reported that the dressings are not sticky enough for being used.No harm or injury reported.

Manufacturer Narrative

H10.H3, h6: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition, it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device is intended for use in treatment.As no samples were returned a thorough product evaluation could not be carried out.However, an image provided demonstrated the reported issue.This confirmed a relationship between the event and the device.Low adhesion may be caused by adhesion levels of the raw material used to make the film of this dressing.There are various controls in place during the manufacturing process of both the raw material and the dressing to identify when the adhesion is not in acceptable range, as per the product specification.There are also regular tests carried out to monitor the finished product.The root cause was traced to manufacturing.The current occurrence rate is within our acceptable range, therefore, no further actions by smith + nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE FLEXIFIX 15CMX10M CTN 1
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10145935
• MDR Text Key: 194877319
• Report Number: 8043484-2020-00686
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66000375
• Device Lot Number: 1827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1