MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE WOUND DRESSING; DRESSING,WOUND,OCCLUSIVE

Model Number UNKNOWN

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

Patient Problems Edema (1820); Rash (2033); Skin Irritation (2076)

Event Date 10/30/2019

Event Type  Injury  

Event Description

It was reported that the patient presented an allergic reaction (blisters as well as redness and edema) to the dressing which was applied after a knee replacement surgery.The patient was prescribed an oral antihistamine as treatment.Health care providers were not sure if the patient was allergic to latex, but the patient has had reactions to adhesive tape.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as no lot or part numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out across all opsite post-op products.There have been further complaints reported with this issue in the past 4 years.The product was used for treatment.It was reported that during use the patient experienced an adverse skin reaction.Images provided confirmed this.No samples were returned for evaluation.A clinical assessment was carried out.It was concluded: ¿the images provided support the report of blisters (bullae), however, these are not directly around the dressing or in relationship to the contact area of the opsite post-op as it would be if there was a reaction to the dressing or its adhesive.It is not likely they are related to the use of the dressing.Based on the information provided it is unclear if there was a procedural variance during use of the product, or whether any patient medical conditions may have been a causative factor for the reported blister.Per the ifu ¿do not use the dressing under compressive dressings or garments¿ and ¿ensure the foam pad is not compressed.¿ if the opsite post-op dressing is applied compressed the foam beneath it can expand and can pull serous fluid into the empty spaces in an area with mobilized fluid and give off blister appearances.The redness and the edema is expected during the post-op healing phase, however, it cannot be definitively concluded that the root cause of the reported allergic reaction/ itching/burning is a direct result of using the opsite post-op dressing.This case documents that the patient has a pre-existing allergy to certain adhesives, and it is uncertain if the reaction the patient experienced is due to an allergy to medical adhesive or the result of a non-allergic irritation caused by one or more chemicals in the adhesive.No further clinical assessment a thorough medical assessment cannot be rendered at this time.¿ a risk management review was carried out.The risk files for this product contains type 4 sensitisation as a potential harm linked to allergies from latex and other components in the adhesive.It also contains type 4 sensitisation linked to incorrect application such as holding the dressing down with film or cutting the dressing.We have been unable to confirm a relationship between the event and device or identify a definitive root cause on this occasion.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 WOUND DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9384871
• MDR Text Key: 168272551
• Report Number: 8043484-2019-00870
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other