MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SECURA NO-STING BARRIER FILM; TAPE AND BANDAGE, ADHESIVE

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2018

Event Type  malfunction  

Event Description

It was reported that secure was used to protect wound edge at end of surgery.Small bleeding treated with electrode switchpen.Vapor from secure was lit with visual flames.Put out within seconds with no harm to patient or staff.

Manufacturer Narrative

Device was not evaluated due to no samples were returned for investigation.Investigation results: we have now concluded our investigation into this report of skin prep no sting wipes.It can be confirmed that each batch released to market undergoes full testing as outlined in the finished product specification, and must comply with all the requirements.The associated skin prep no sting wipe product information for use (ifu) leaflet states the following: secura no-sting barrier films is flammable: use in a well-ventilated area.Avoid using around flames and sources of ignition.Keep out of the reach of children.For external use only.Additionally, complaints of a similar nature will be closely monitored for any adverse trends and further action considered.

• Brand Name: SECURA NO-STING BARRIER FILM
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7376530
• MDR Text Key: 103643246
• Report Number: 8043484-2018-00071
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K092712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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