MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-06-14 for 3M CAVILON NO STING BARRIER FILM 3345 manufactured by 3m Health Care.
[47333854]
(b)(4). Company 3m received 3500a report # 500770000-2016-8029 from facility. Packing and instructions for use were reviewed. Packing label states: warning! Extremely flammable caution, see instructions for use. Instructions for use state the following...... Warning: cavilon no sting barrier film is extremely flammable until it has completely dried on the skin. Cavilon no sting barrier film should only be applied when no ignition sources or heat-producing devices are in use....... Instructions for use in a surgical setting: refer to the warnings section of this information. When used in a surgical environment, use of cavilon no sting barrier film should be discussed during the "time out" period for verification of surgical procedure and site....
Patient Sequence No: 1, Text Type: N, H10
[47333855]
Customer reported cavilon no sting barrier film was applied to a patient's abdomen in the operating room (o. R. ) during a wound vac procedure. The md reportedly used a cautery shortly after the cavilon no sting barrier film was applied. A flash flame occurred and the md and surgical nurse reportedly extinguished the flame in less than 10 seconds. The patient was assessed and did not sustain any injury. The md sustained a first degree burn to his left ring finger and no treatment was required for his injury. The scrub nurse reportedly sustained 2nd and 3rd degree burns to her arm. The reporter did not have information regarding treatment for the scrub nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00064 |
| MDR Report Key | 5723201 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-14 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KAREN KRENIK, BSN |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2016-06-14 |
| Catalog Number | 3345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-14 |