MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-29 for 3M CAVILON ADVANCED SKIN PROTECTANT 5050 manufactured by 3m Health Care.
[61084128]
Company representative reported she applied 5050 cavilon advanced skin protectant to her inner arm and thigh as a trial. She reportedly experienced itching and initially and used otc oral benadryl and topical hydrocortisone for treatment. Three days after application to her inner arm she reportedly experienced contact dermatitis (itching and hives) and self treated with a medrol dosepack and otc hydrocortisone cream. The following day the reaction felt better but reportedly returned nine days later. She also reportedly experienced a contact dermatitis (itching and hives) three days after application to her thigh. She saw a dermatologist who reportedly diagnosed this as a reaction to 5050 cavilon advanced skin protectant. The dermatologist recommended benadryl (oral) 50 mg at night, allegra 180 mg every day x 2 weeks, and topical rx fluocinonide 0. 05% cream for treatment. The rash was reportedly improving. She reportedly has sensitive skin, sensitivity to adhesives, a history of many allergies and has experienced hives to both pcn and latex..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00106 |
| MDR Report Key | 6133558 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-11-06 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-11-29 |
| 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 |
| Manufacturer G1 | 3M COMPANY 3M COLUMBIA |
| Manufacturer Street | 5400 PARIS ROAD |
| Manufacturer City | COLUMBIA MO 65202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M CAVILON ADVANCED SKIN PROTECTANT |
| Generic Name | CAVILON ADVANCED SKIN PROTECTANT |
| Product Code | KMF |
| Date Received | 2016-11-29 |
| Catalog Number | 5050 |
| Lot Number | UNK |
| 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 | 2016-11-29 |