MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE; BANDAGE, ELASTIC

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

Patient Problems Pain (1994); Post Traumatic Wound Infection (2447)

Event Type  Injury  

Event Description

It was reported that in a study of a pilot multi-centre prospective randomised controlled trial of recell for the treatment of venous leg ulcers, the clinical benefit of the addition of autologous skin cell suspension (ascs) treatment to standard practice (debridement and cleansing) followed immediately by placement of non-adherent telfa clear (covidien, dublin, ireland) wound dressing and multi-layer compression bandages (profore, smith and nephew, london, uk) was compared with standard practice (debridement and cleansing) followed immediately by placement of non-adherent telfa clear (covidien, dublin, ireland) wound dressing and multilayer compression bandages (profore) without ascs treatment.During the study a total of 7 treatment-related wound infections occurred.It is unknown how many patients were having pain and how were they treated.

Manufacturer Narrative

H10.H3, h6: this investigation is born from the review of an historic clinical trial.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.As no product code or batch/lot number has been provided we were unable to conduct a review of the device¿s history.However, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported events has been reviewed, revealing further instances.A review of the associated risk files found various failure modes leading to pain such as, insufficient padding under dressing, too much pressure when wrapping the dressing and pins and clips used to hold dressing in contact with skin.The file also contains multiple causes of local infection including damaged packaging, damaged dressing and poor patient compliance.Without further information into the causes of these harms, a more precise failure mode cannot be stated.The file also contains the failure mode of the dressing being left on too long leading to light bleeding.The ifu and device labeling contain adequate warnings and caution in respect of the reported events, including, do not use on patients with an ankle brachial pressure index (abpi) of less than 0.8, or on diabetic patients with advanced small vessel disease.Should the patient develop pain or pale, cool or numb extremities distal to the dressing, the bandages should be promptly removed.If the patient has a very thin ankle or very prominent tibial crest, extra padding should be applied to these areas to prevent pressure necrosis.Failure to detect significantly reduced arterial flow can result in pressure necrosis, amputation or even death.This product has components that contain natural rubber latex which may cause allergic reactions in some individuals.The risk of arterial as well as venous disease rises with age.The device, used in treatment, was not returned for evaluation.We have been unable to confirm a relationship between the event and the device or identify a root cause on this occasion.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.

• Brand Name: PROFORE
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10114007
• MDR Text Key: 193629073
• Report Number: 8043484-2020-00618
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention