MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN CONFORMANT 2; DRESSING, WOUND, HYDROPHILIC

Catalog Number UNKN05004501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulcer (2274); Impaired Healing (2378)

Event Date 05/27/2021

Event Type  Injury  

Event Description

It was reported that, when using conformant 2 to treat patients with leg ulcers, a patient indicated that the wound did not improve or heal appropriately during the period of treatment.It was also reported that the patient did not show up for treatment appointments until the wound got to stage 4 ulcer.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.Furthermore, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include application, removal, time left on patient, trauma, materials used within the dressing.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.No lot/serial number has been provided, therefore a review of manufacturing records is not possible.A complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKN CONFORMANT 2
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12025546
• MDR Text Key: 257225567
• Report Number: 8043484-2021-01522
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other