MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-18 for CAVILON 3345 manufactured by 3m Company, 3m Health Care.
[42876656]
Patient Sequence No: 1, Text Type: N, H10
[42876657]
A cavilon skin barrier film was utilized within the operating room on a trauma patient who was undergoing abdominal surgery. Cautery was used on a bleeder prior to the product being dry. As a result, there was a vaporization flash/flame. There was no harm to the patient, staff, or any items in the operating room. Staff is very concerned about the lack of labeling on this product. There is only one package insert in a box of 25 products, which could easily be misplaced. There is only one warning re: "extremely flammable" on one end corner of the box itself. Within the operating arena, a single individual packet is brought in, not the entire box. The actual individual product has one small statement on the reverse side of the product at the top. When the product is opened for use, the top which contains the warning is detached and discarded, and the warning may not even be read. Note: i have photos of the product and will forward any upon request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5584033 |
| MDR Report Key | 5584033 |
| Date Received | 2016-04-18 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-08 |
| Report Date | 2016-03-01 |
| Date Reported to FDA | 2016-03-01 |
| Date Reported to Mfgr | 2016-03-01 |
| Date Added to Maude | 2016-04-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 2016-04-18 |
| Catalog Number | 3345 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY, 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER 2510 CONWAY AVE. BUILDING 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-18 |