MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM USA CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4628
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after removing opsite flexigrid 6x7 cm ctn 100, the patient experienced red and swollen skin with itchy sensation.These adverse effects were treated with a magnesium sulfate injection.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: we have now concluded our investigation into the reported complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.It was therefore not possible to establish a relationship between the reported event and the device.It was reported that the patient experienced redness, swelling, and itchy sensation which lasted two days.The reaction was treated with medication and the current patient status was reported as ¿normal.¿ since no further harm is anticipated, no further clinical/medical assessment is warranted at this time.It has not been possible to establish the root cause of the issue.Probable root cause is a patient reaction to one or more of the materials in the dressing.Users of the device are advised to consult the instructions for use, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.The user risk assessment for the device provides details of possible sensitisation reactions and irritation or irritants contact dermatitis, as possible harms caused by toxicology of the materials used in the dressing.The investigation has been closed.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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: OPSITE FLEXIGRID 6X7CM USA CTN 100
• Common Device Name: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11921042
• Report Number: 8043484-2021-01339
• Device Sequence Number: 3268490
• Product Code: KGX
• UDI-Device Identifier: 05000223438500
• UDI-Public: 5000223438500
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 4628
• Device Lot Number: 1922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male