MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 5X6.5CM CTN 30; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66030313

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 04/06/2020

Event Type  malfunction  

Event Description

It was reported that the adhesive power was too low.Skin was cleaned before applying the dressing.It is unknown if a back-up was available to continue treatment.No information about delay or patient harm.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and 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.

Manufacturer Narrative

H10, h3, h6: the device, used in treatment, has not been returned for evaluation.Due to this we cannot assess the individual product and we are unable to confirm a relationship between the event and the device or identify a root cause on this occasion.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 for the reported failure has been reviewed which shows further instances of this reported failure.The wound contact surface of opsite flexifix gentle is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.No further actions 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 POST OP 5X6.5CM CTN 30
• 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: 10172709
• MDR Text Key: 195742159
• Report Number: 8043484-2020-00856
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223453169
• UDI-Public: 5000223453169
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2021

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: 66030313
• Device Lot Number: 201937
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 09/06/2021
• Supplement Dates FDA Received: 09/16/2020; 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1