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 2018-03-16 for 3M CAVILON NO STING BARRIER FILM 3345E manufactured by 3m Health Care.
[102702877]
The lot number was not provided. Without a lot number, expiration date and manufacturer date cannot be determined. Confidential: manufacturer: (b)(4). The customer reported a young surgeon had not received cavilon no sting barrier film product training prior to use. The surgeon reportedly used the electric scalpel before the cavilon no sting barrier film had been allowed to dry. The product instructions for use contain the following warnings and instructions for use in the surgical setting:.... 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..... Directions 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.... This product is labeled as highly flammable and the packaging contains a flame symbol.
Patient Sequence No: 1, Text Type: N, H10
[102702878]
A hospital employee reported cavilon no sting barrier film was applied to a patient's skin during an unspecified surgical procedure. An electric scalpel was used before the product was allowed to dry and the patient's skin ignited. The patient allegedly experienced a first degree burn. An unspecified ointment was used for treatment and the injury was reportedly resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00030 |
| MDR Report Key | 7346351 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-03-16 |
| 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 | 3M CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2018-03-16 |
| Catalog Number | 3345E |
| Operator | PHYSICIAN |
| 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 | 2018-03-16 |