MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-05-15 for CAVILON NO STING BARRIER FILM 3345N manufactured by 3m Health Care.
[75207290]
Lot number was reported as either 2018-09na or 2018-07ma. For lot # 2018-09na, the expiration date is: 09/28/2018 and the manufacturer date is: 09/2015. For lot number 2018-07ma, the expiration date is: 07/28/2018 and the manufacturer date is: 07/2015. (b)(4). Current packaging states the following: warning! Extremely flammable caution, see instructions for use. There is also a orange flame symbol on the bottle. This product, 3345n is not sold in the u. S. ; the instructions for use contain only non-english languages.
Patient Sequence No: 1, Text Type: N, H10
[75207291]
Customer reported that during surgery, a 3345n cavilon no sting barrier film wand caught fire when a diathermy knife was used in close proximity. Reportedly, the patient experienced redness and the surgeon's eyebrows were burnt. No additional information was available to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00076 |
| MDR Report Key | 6568183 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-05-15 |
| 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 | CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2017-05-15 |
| Catalog Number | 3345N |
| Lot Number | 2018-09NA OR 2018-07MA |
| Device Expiration Date | 2018-09-28 |
| 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 | 2017-05-15 |