MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-08 for 5050 3M? CAVILON? ADVANCED SKIN PROTECTANT N/A manufactured by 3m Health Care.
[107632949]
The lot number was not provided. Without a lot number, expiration date and manufacturer date could not be determined. A review of complaints was completed and there have been no previous complaints for a fungal infection. The customer reported it was unknown if other products were on the patient's skin prior to application of 5050 cavilon? Advanced skin protectant. The product ifu, under precautions, states that use of other barrier products, ointments, creams or lotions may significantly reduce the effectiveness of the product. End of report.
Patient Sequence No: 1, Text Type: N, H10
[107632950]
A nurse reported 5050 3m? Cavilon? Advanced skin protectant was applied to a patient's perineal and buttocks area. Prior to application, the patient's skin was red, irritated, and had open areas with exposed dermis. The patient also had an existing skin tear in her sacral area. 5050 3m? Cavilon? Advanced skin protectant was applied to protect the patient's skin from frequent loose stools and urination. It was unknown if there was existing barrier cream on her skin prior to application of the 5050 cavilon advanced skin protectant. The patient was seen three days after application and the nurse reported the patient had an extensive fungal infection in the perineum, labia and thighs. In addition, the existing open area and the skin tear had allegedly increased in size. The 5050 3m? Cavilon? Advanced skin protectant was discontinued and a zinc, miconazole and lidocaine ointment mixture (compounded by pharmacy) was used for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00050 |
| MDR Report Key | 7495153 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-04-17 |
| Date Added to Maude | 2018-05-08 |
| 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 | BRENDAN CASEY, PH.D. |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374488 |
| 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 | 5050 3M? CAVILON? ADVANCED SKIN PROTECTANT |
| Generic Name | CAVILON? ADVANCED SKIN PROTECTANT |
| Product Code | KMF |
| Date Received | 2018-05-08 |
| Model Number | N/A |
| Catalog Number | 5050 |
| Lot Number | UNK |
| Operator | NURSE |
| 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 | 2018-05-08 |