MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 10CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66000041
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that when the separation of the opsite flexifix 10cmx10m ctn 1 was initiated, to send the patient to the resident, the product was found to have the back of the dressing adhered to the roller, when trying to remove it, the product began to get damaged.No delay to the treatment reported or patient harm.
Additional Manufacturer Narrative
Section: h3, h6: 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 found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that the dressing adhered to the backing when it was attempted to peel it.Probable root cause is an environmental issue such as temperature.A change in temperature can alter the adhesive nature of the dressing making it adhere to the backing paper.The device must be stored in accordance with the conditions detailed in the ifu.The users of the reported product are therefore advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device should be stored 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 FLEXIFIX 10CMX10M CTN 1
• 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: 12509990
• Report Number: 8043484-2021-01784
• Device Sequence Number: 19740944
• Product Code: KGX
• UDI-Device Identifier: 05000223411473
• UDI-Public: 5000223411473
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 66000041
• Device Lot Number: 2110
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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
• Patient Sex: Unknown