MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-27 for 3M? CAVILON? NO STING BARRIER FILM N/A 3344E manufactured by 3m Health Care.
[137306749]
This complaint is for a flammability event that occurred in (b)(6) 2018. The flammability event is not due to a product defect or problem with this specific lot. The product is flammable until it is completely dry and vapors have dissipated. There is flammability information in the cavilon no sting barrier film catalog number 3344e ifu and a flame symbol on each individual pouch. For this application, cavilon no sting barrier film catalog number 3344e is provided non-sterile to kci as a component of their kit. Cautery was the ignition source for this event. The physician was reportedly aware that cavilon no sting barrier film, 3344e was flammable.
Patient Sequence No: 1, Text Type: N, H10
[137306750]
A distributor recently reported that approximately one year ago, 3m cavilon? No sting barrier film was applied to a patient's skin prior to placement of a wound vac device. A physician reportedly used a bovie cautery device following application of the cavilon no sting barrier film. A flammability event occurred, and the patient experienced a small first-degree burn described as a small area of redness. The distributor reported there was no indication that the patient required additional medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00031 |
| MDR Report Key | 8375366 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-27 |
| 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 | DIANNE GIBBS |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M HEALTH CARE LIMITED |
| Manufacturer Street | DERBY ROAD |
| Manufacturer City | LOUGHBOROUGH, LEICESTERSHIRE LE115SF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE11 5SF |
| 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 | 2019-02-27 |
| Model Number | N/A |
| Catalog Number | 3344E |
| 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 | 2019-02-27 |