MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX GENTLE 10CMX5M; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66801197

Device Problems Loss of or Failure to Bond (1068); Device Difficult to Setup or Prepare (1487); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

It was reported that during inspection the opsite flexfix dressing did not stick.No harm or injury reported.

Manufacturer Narrative

H10: h3, h6: the device, intended to be used in treatment, has not been returned for evaluation.No additional information was provided.Therefore we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found additional complaints for the product and failure mode reported in the last three years.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.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.

Manufacturer Narrative

Reassessment of this incident found it not to fulfill reporting criteria.A device that is difficult to setup or prepare device would not be likely to cause or contribute to a death or serious injury.Event may result in minor or temporary injury (e.G., pain) requiring no or minor medical intervention.The event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.While this event is no longer considered reportable, this report is being submitted as a courtesy to provide updated investigation results based on the return and evaluation of the complaint device subsequent to the submission of our previous supplemental report.The device was returned for evaluation, confirming the reported event.Visual inspection confirmed silicone remained on the carrier, functional evaluation confirmed reduced adherence.A documentation investigation has been conducted, confirming that no manufacturing or process problems have been observed.Complaint history shows previous events of this nature, with corrective actions assigned, which are in the effectiveness stage.The root cause has been deemed a component failure, the instructions for use, detail the wound contact layer within these dressing can be affected by storage temperature fluctuations.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no additional corrective actions deemed necessary.

• Brand Name: OPSITE FLEXIFIX GENTLE 10CMX5M
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10388768
• MDR Text Key: 202339895
• Report Number: 8043484-2020-02371
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2022

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: 66801197
• Device Lot Number: 1337701905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 04/28/2022
• Supplement Dates FDA Received: 12/04/2020; 05/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1