MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-16 for CAVILON NO STING BARRIER FILM 3346 manufactured by 3m Health Care.
[75256403]
(b)(4). Current packaging states the following: warning! Extremely flammable caution, see instructions for use. The packaging artwork is in the process of being updated to include the red diamond flame symbol. Instructions for use state the following: warnings: danger! Highly flammable! Cavilon no sting barrier film is highly 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. Avoid using around flames. Use in a well ventilated area.
Patient Sequence No: 1, Text Type: N, H10
[75256405]
Customer reported she applied 3346 cavilon no sting barrier film spray to a cut in her genital area and rubbed it in with her hand. She reportedly lit a cigarette and her hand ignited in flames. She was reportedly transported to the hospital via ambulance. She allegedly experienced a 2nd degree burn to her palm and a 3rd degree burn to the top portion of her hand. She was reportedly treated for pain with iv and im dilaudid while in the emergency room. She was now using oral dilaudid and silvadene cream for treatment and further follow up has been scheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00077 |
| MDR Report Key | 6569542 |
| Report Source | OTHER |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2017-05-16 |
| Catalog Number | 3346 |
| Operator | LAY USER/PATIENT |
| 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; 2. Required No Informationntervention | 2017-05-16 |