MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-04-09 for 3M? CAVILON? NO STING BARRIER FILM N/A 3344 manufactured by 3m Health Care.
[104802050]
On (b)(6) 2018 was used for the date of the event. This was reportedly an ongoing issue and skin irritation was first reported in (b)(6). The lot number was not provided. Without a lot number, expiration date and manufacturer date could not be determined. (b)(4). The patient reportedly consulted a dermatologist for patch testing which showed positive results for adhesives and acrylates. The patient reportedly had very sensitive skin and was using multiple adhesive products, ointments and creams on his stoma site. The patient's reaction improved when he discontinued all products except the ostomy pouch and used triamcinolone acetonide spray for treatment. This report was sent to the fda because 3m? Cavilon? No sting barrier film was reportedly one of the products used on his stoma site.
Patient Sequence No: 1, Text Type: N, H10
[104802111]
A patient's wife reported her husband had a urostomy created in (b)(6) 2018. In (b)(6) he experienced skin irritation around his stoma. An internist diagnosed the irritation as folliculitis and prescribed an unspecified oral antibiotic. The irritation improved until (b)(6) when the skin around his stoma became bright red and weepy. He was reportedly using several different ostomy products around his stoma including 3m? Cavilon? No sting barrier film, an ostomy pouch, an ostomy paste, ostomy glue and barrier strips/ rings. He was also periodically using otc ointments and creams for treatment. He consulted a dermatologist, was patch tested and showed positive results for adhesives and acrylates. He was instructed to use only water for cleansing around his stoma, to discontinue use of 3m? Cavilon? No sting barrier film and all other ostomy products except for the ostomy pouch. He was given a rx for triamcinolone acetonide spray and was instructed to discontinue use of all otc ointments and creams. The skin around his ostomy has reportedly improved over the last couple of weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00041 |
| MDR Report Key | 7409712 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-03-28 |
| Date Added to Maude | 2018-04-09 |
| 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 | 2018-04-09 |
| Model Number | N/A |
| Catalog Number | 3344 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 2018-04-09 |