MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-03-15 for 3M CAVILON NO STING BARRIER FILM 3345E manufactured by 3m Health Care.
[102455540]
Manufacturer: (b)(4). A 3ml wand of 3345e cavilon no sting barrier film was reportedly applied to a (b)(6) y/o patient's cheek prior to application of fixomull stretch. It was unknown if the cavilon no sting barrier film was allowed to dry prior to application of the fixomull stretch. The cavilon no sting barrier film directions for use state to allow the product to thoroughly dry before covering with dressings, tapes or other adhesive products.
Patient Sequence No: 1, Text Type: N, H10
[102455541]
A hospital employee reported 3345e cavilon no sting barrier film was applied to a (b)(6) y/o male patient's cheek prior to application of fixomull stretch. When the fixomull stretch was removed, the patient experienced redness and swelling of the right cheek. Clobetasone butyrate, a topical rx ointment, was used for treatment and the reaction was reportedly improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00029 |
| MDR Report Key | 7340936 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-02-25 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-03-15 |
| 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 | 3M CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2018-03-15 |
| Catalog Number | 3345E |
| Lot Number | 2020 11 AA |
| 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. Required No Informationntervention | 2018-03-15 |