MAUDE Adverse Event Report: CONVATEC INC TRIO; PROTECTOR, OSTOMY

Model Number 423288

Device Problems Fire (1245); Off-Label Use (1494); Flare or Flash (2942)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Type  malfunction  

Event Description

It was reported by the distributor that during a cardiovascular surgery in pediatrics at the hospital, on a one-year-old girl, the surgeons applied company's known remover spray to remove the antimicrobial incise drape.The skin was washed with a microbicidal skin cleaner solution and subsequently washed and debrided the external wound and then applied company's known skin protector in a wet towel presentation with the aim of applying the new antimicrobial incise drape.The surgery resident identified a suture that was bleeding and proceeded to turn on the electro-scalpel to correct the bleeding.A flame was immediately generated in the pediatric intensive care unit (icu) cubicle where they were performing the procedure.The surgical fields were burned, the foam from the negative pressure system that was covering the wound bed and as an immediate reaction, the surgery resident picked up the surgical fields that were on fire covering the girl, to prevent her from burning.At the time of the fire, the open sternotomy and the wound bed were covered by two foams: a white foam in direct contact with the heart and on top of it a black foam from the negative pressure system.Apparently, no burns were caused to the medical and nursing staff (children's cardiovascular surgeon, cardiovascular surgery resident, surgical instrument technician and nursing assistant) who were present at the time of the incident nor to the medical teams, but the institution will verify further in detail the status of the equipment and personnel.The institution's engineering team verified whether the fire was caused by a leak, but they found no leaks in either the cubicle or the pediatric intensive care unit (icu) service.The girl have a grade ii skin burn.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

E1: complainant city: (b)(6).Complainant state: antioquia complainant country: colombia name of affiliation: tecnomedica name of hospital: (b)(6).Patient city: (b)(6).Patient state/province:(b)(6).A2: age at time of event - 1 year brand name : antimicrobial incise drape - ioban microbicidal skin cleaner - prepodyne the device has malfunctioned and would be likely to cause or contribute to a death or serious injury if it were to recur.Based on the circumstances of the reported complaint, the case has been submitted as a reportable malfunction and there was minor harm experienced, and it has been reported under imdrf health impact code and clinical code.Based on the available information, this event is deemed to be a reportable malfunction.A review of the ifu by the convatec clinical team indicated noted the flammable warnings are included on the product and the product packaging has the necessary warning symbols to highlight this.The ifu also includes warnings to keep away from ignition sources and sparks.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 third party manufacturing site: 3010605379.

Manufacturer Narrative

Correction (d5): the incorrect operator of device was submitted along with initial emdr 1843238 with mfg report number: on 03/15/2024.However, the correct operator of device for initial emdr should be health professional.Please disregard the previous one.Additional information - this emdr is being submitted to include the below information: describe event or problem (b5): - it was mentioned that the patient unfortunately died.However, the cause of death and date of death is unknown.To date there has been no further communication with the clinic nor have they or the family members made a formal claim to company.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Third party manufacturing site: 3010605379.

Event Description

To date, additional patient or event details were received which have been added in h11 (addl mfg narrative).

• Brand Name: TRIO
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18911671
• MDR Text Key: 337740792
• Report Number: 1049092-2024-00023
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 423288
• Device Lot Number: 233737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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
• Patient Sex: Female