MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-27 for CAVILON NO STING BARRIER FILM 3344 manufactured by 3m Health Care.
[78474801]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78474802]
Customer reported an outpatient with metastatic colon cancer had an implanted port located in her chest. The implanted port was accessed for an iv treatment of 5fu (chemotherapy). Cavilon no sting barrier film was reportedly applied to the site and then covered with a tegaderm iv transparent film dressing with adhesive free window. The patient went home and the infusion was scheduled to run for 46 hours. When the infusion finished, the outpatient removed the dressing and de-accessed the site. Two days after removal of the dressing, the patient reportedly experienced redness and blistering under the entire area where cavilon no sting barrier film and the dressing had been applied. The patient's therapy was reportedly held due to her skin condition and she was treated with oral antibiotics and an otc topical steroid cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00089 |
| MDR Report Key | 6669825 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-06-05 |
| Date Added to Maude | 2017-06-27 |
| 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 | CAVILON NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2017-06-27 |
| Catalog Number | 3344 |
| 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 | 2017-06-27 |