MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-13 for 3M CAVILON NO STING BARRIER FILM 3345 manufactured by 3m Health Care.
[85956570]
Confidential: manufacturer: (b)(4). Type of reportable event: this report did not involve a death, serious injury or product malfunction. A selection in this area was required so serious injury was selected. Instructions for use contain the following information: 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. The customer reported the facility followed- up with complete product and fire safety/ prevention training for staff and surgeons.
Patient Sequence No: 1, Text Type: N, H10
[85956571]
A nurse reported 3345 cavilon no sting barrier film was applied in the operating room to a patient's wound edge following a debridement procedure. A surgeon ignited a bovie cautery before the product was allowed to dry and a flash fire/burn occurred. The patient was monitored closely following the incident and did not experience a burn or any other adverse consequence. No additional medical treatment was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00113 |
| MDR Report Key | 6861769 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-13 |
| 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 | 2017-09-13 |
| 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 | 2017-09-13 |