MAUDE Adverse Event Report: CONVATEC INC L3O0625 - TRIO

Model Number 423281

Device Problem Electro-Static Discharge (2149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported by nurse practitioner of safety department who received a report from the neonatal ward that adhesive remover wipe inflamed right away while it was unpacked and caught fire, resulting in a very small fire that was immediately extinguished by the nurse.There was neither damage to the patient nor to anything regarding the facility.Customer suspected electrostatic air with sparking as the cause, not the product itself.There was no high flow oxygen involved, however, product labeling stated that this wipe is a highly flammable product which appears that if it had malfunctioned and would be likely to cause or contribute to a death or serious injury if it were to recur as per guidelines.It was assumed that an electrostatic discharge caused or contributed to the fire by a protective gown made of a cotton polyester blend.The customer will replace all protective gowns with full cotton gowns.The wipe was not used on the patient.No photo is available at this time.

• Brand Name: L3O0625 - TRIO
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 211 american avenue; greensboro, NC ; 3365424681
• MDR Report Key: 13967929
• MDR Text Key: 298199845
• Report Number: 1049092-2022-00088
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 423281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/31/2022
• 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: Unknown
• Patient Sequence Number: 1