MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-09-20 for 3M CAVILON NO STING BARRIER FILM 3343N manufactured by 3m Health Care.
[86829773]
Confidential: manufacturer: (b)(4). This product, 3343n is not sold in the u. S. ; the instructions for use contain only non-english languages. Instructions for use contain the following information:.... Warnings danger! Extremely flammable! 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. Avoid using around flames. Use in a well ventilated area. According to the hospital, the event was caused by the operator being disturbed at the end of the operation, which led to a lack of communication between the operator and the surgery nurse. Now, a new routine has been introduced for the device: before use of cavilon no sting barrier film, the electrical connection to the diathermy should be disconnected. Information about the new routine has been communicated within the hospital.
Patient Sequence No: 1, Text Type: N, H10
[86829774]
An elderly female patient experienced a mild burn when 3343n cavilon no sting barrier film was applied to her wound edge following an unspecified operation. The operator reportedly used an electrical diathermic device to stop bleeding after the product was applied. The cavilon no sting barrier film reportedly caught fire and was immediately terminated by the nurse. The patient did not require any additional medical treatment and was reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00121 |
| MDR Report Key | 6881099 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-09-20 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-05-28 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-09-20 |
| 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 | 2017-09-20 |
| Catalog Number | 3343N |
| Lot Number | UNK |
| 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 | 2017-09-20 |