MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-17 for CAVILON 3345 CAVILON NO STING BARRIER FILM 3345 manufactured by 3m Company.
[52388261]
Patient Sequence No: 1, Text Type: N, H10
[52388262]
In the operating room during a wound vac replacement, a flash flame of fire developed after skin prepped with cavilon no sting barrier and a bovie was brought onto the field. The abdomen was swabbed with the cavilon sponge and incidentally the surgeon saw a blister, not related to the initial surgery, he popped and grabbed the bovie to stop the blister from draining shortly after the cavilon was applied. Both the surgeon and rn patted the patient's abdomen. Flame was out in less than 10 seconds. The embers caught on to the physician's gown which caught on fire and he patted the flames away. The patient was assessed and did not sustain any injury. Patient's skin was clear, no redness, no blistering. The rn sustained second and third degree burns. The physician sustained a first degree burn.
Patient Sequence No: 1, Text Type: D, B5
[83330339]
Patient Sequence No: 1, Text Type: N, H10
[83330340]
In the or during a wound vac replacement, a flash flame of fire developed after skin prepped with cavilon no sting barrier and a bovie was brought onto the field. The abdomen was swabbed with the cavilon sponge and incidentally the surgeon saw a blister, not related to the initial surgery, he popped and grabbed the bovie to stop the blister from draining shortly after the cavilon was applied. Both the surgeon and rn patted the patients abdomen. Flame was out in less than 10 seconds. The embers caught on to the physician's gown which caught on fire and he patted the flames away. The patient was assessed and did not sustain any injury. Patient's skin was clear, no redness, no blistering. The rn sustained second and third degree burns. The physician sustained a first degree burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5882588 |
| MDR Report Key | 5882588 |
| Date Received | 2016-08-17 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-05-06 |
| Report Date | 2016-05-18 |
| Date Reported to FDA | 2016-05-18 |
| Date Reported to Mfgr | 2016-05-18 |
| Date Added to Maude | 2016-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVILON |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2016-08-17 |
| Model Number | 3345 CAVILON NO STING BARRIER FILM |
| Catalog Number | 3345 |
| Lot Number | NA |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE BUILDING 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-17 |