MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-16 for 3M CAVILON NO STING BARRIER SPRAY manufactured by 3m Health Care Ltd..
[2520961]
The pt came to the dermatology dept due to persistent severe peristomal dermatitis. She brought with her the products she used for her ileostomy site. She was found to have a severe blistering reaction to 3m cavilon no-sting barrier spray when patch tested to her products, the no sting barrier spray is used to "protect" the area. We contacted 3m who said they have had reports of similar reactions from this product, but when searching maude, no other have been reported to the fda. 3m declined to send the individual ingredients in there cavilon no-sting barrier spray to determine what within the product was causing the pt to have the bullous reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024300 |
| MDR Report Key | 2465606 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-02-16 |
| Date of Event | 2011-11-16 |
| Date Added to Maude | 2012-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M CAVILON NO STING BARRIER SPRAY |
| Generic Name | 3M CAVILON NO STING BARRIER SPRAY, 28 ML |
| Product Code | KOY |
| Date Received | 2012-02-16 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE LTD. |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-16 |