MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE LITE SYSTEM KIT CASE 8; BANDAGE, ELASTIC

Catalog Number 66000415

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 02/09/2019

Event Type  Injury  

Event Description

It was reported that one member of the medical staff was putting this dressing on a patient and began to have an allergic reaction to the latex.She developed a rash and shortness of breath.The staff member had allergy medication available and symptoms improved quickly.

Manufacturer Narrative

We have now concluded our investigation into this complaint.A dhr was not conducted as this complaint relating to a reaction to latex and not a manufacturing issue.No complaint sample was available at this time.A clinical review found that the most likely root cause was unfamiliarity with the latex and latex free product packaging.The reported allergic reaction was relieved with allergy medication and the symptoms improved quickly.As part of the investigation, the ifu was reviewed and it was found to contain a caution that the product does contain natural rubber latex which may cause allergic reactions.No further action is deemed necessary at this time.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PROFORE LITE SYSTEM KIT CASE 8
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8412195
• MDR Text Key: 138529661
• Report Number: 8043484-2019-00168
• 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,u
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66000415
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention