MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN GENTLE (GENERATION II); DRESSING, WOUND, OCCLUSIVE

Catalog Number UNKN05000509

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

Patient Problems Pressure Sores (2326); Tissue Breakdown (2681)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that, when using allevyn gentle dressing to treat patients with diabetic foot ulcers, it was reported that the patient did not get better as patient would not offload the area-developed second wound on her leg and ended up with a left bka.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, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.

Manufacturer Narrative

H3, h6: the complaint was received as a result of issues being identified in a post market clinical survey.Due to this, no specific product details or batch/lot numbers have been available to the investigation.As a result of this, no device history review was possible.A complaint history review was performed for the product family and event description, there have been further instances in the past three years.According to the survey, the devices were being used in patient treatment.The devices used for treatment have not been returned to smith and nephew for analysis.We have therefore not been able to confirm a relationship between the event and the device or identify a definitive root cause.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The medical review could not establish a link between the product and harm within this complaint and therefore additional rmr is not required.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, including advice on application and removal of dressings.This investigation has now been closed.No further actions by smith and nephew are deemed necessary at this stage.Smith and nephew acknowledge customer concern and are grateful for all feedback on our products, as this information is extremely valuable to us, as we are continually investigating ways to develop and improve the full range of products that we provide.We will continue to monitor for any adverse trends relating to all product ranges.

Manufacturer Narrative

H3, h6: it was reported that the healthcare professional was not satisfied with allevyn gentle's wound area improvement when asked to provide their assessment of the performance of the product as a wound management dressing for diabetic foot ulcers throughout patient¿s treatment.The user indicated that the wound did not get better as the patient did not offload the area.A second wound was developed on patient's leg and ended up requiring a below-knee amputation.This event was described 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, we do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.The device was not returned for analysis.We have therefore not been able to confirm a relationship between the event and the device, or identify a definitive root cause.A complaint history review was performed for the product family and event description, there have been further instances in the past three years.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.The medical review could not establish a link between the product and harm within this complaint and therefore additional rmr is not required.Due the circumstances of this complaint and in the absence of the device(s) for examination, it is not possible to hypothesise a probable root cause for this complaint.Possible causes could be inadequate skin preparation, incorrect use of the dressing or the wrong dressing being used for the level of wound.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, including advice on application and removal of dressings.This investigation is now complete.No further actions by smith and nephew are deemed necessary at this stage.Smith and nephew acknowledge customer concern and are grateful for all feedback on our products, as this information is extremely valuable to us, as we are continually investigating ways to develop and improve the full range of products that we provide.We will continue to monitor for any adverse trends relating to all product ranges.H6, h10.

• Brand Name: UNKN ALLEVYN GENTLE (GENERATION II)
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• 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: 12026295
• MDR Text Key: 257233393
• Report Number: 8043484-2021-01537
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05000509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 03/23/2023; 03/23/2023
• Supplement Dates FDA Received: 09/09/2021; 03/24/2023; 03/24/2023
• 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
• Patient Outcome(s): Other