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 2017-12-19 for 3M CAVILON NO STING BARRIER FILM 3344 manufactured by 3m Health Care.
[95256699]
(b)(4). Instructions for use contain the following information:.... Warnings 1. Danger! Extremely flammable! 2. Cavilon no sting barrier film is extremely flammable until it has completely dried on the skin. 3. Cavilon no sting barrier film should only be applied when no ignition sources or heat-producing devices are in use. 4. Avoid using around flames. 5. Use in a well ventilated area...... This product is labeled as extremely flammable. The customer reported a static electric shock occurred. The static discharge was most likely the ignition source for this reported event. 3m is still investigating the potential root cause for this reported event. A review of similar complaints regarding static discharge was completed and no trend was seen.
Patient Sequence No: 1, Text Type: N, H10
[95256700]
A physical therapist reported she visited the home of a (b)(6) male patient for application of kinesio therapeutic tape. Prior to taping, a 3344 cavilon no sting barrier film wipe was opened. A static electric shock occurred as the product was about to be applied to the patient and it ignited into flames. The flames were extinguished very quickly. The patient reportedly experienced a burn in three areas and initially applied aloe for treatment. A physician was consulted and the patient was diagnosed with a second degree burn to his right ankle. The patient was reported to be in stable condition and silvadene cream was being used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00152 |
| MDR Report Key | 7129992 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2017-05-17 |
| Date Added to Maude | 2017-12-19 |
| 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 | 2017-12-19 |
| Catalog Number | 3344 |
| Lot Number | 2020 05 CA |
| Operator | PHYSICAL THERAPIST |
| 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 | 2017-12-19 |