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 2017-02-21 for 3M CAVILON NO STING BARRIER FILM 3346E manufactured by 3m Health Care.
[67924364]
Patient information was not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67924365]
Customer reported a lymphoedema patient had laser therapy to her left foot on an unspecified date. Following the laser treatment (unspecified time span), (b)(4) cavilon no sting barrier film was reportedly applied to the area. The patient reportedly presented with a possible reaction to cavilon no sting barrier film or cellulitis of the left foot and was sent to the emergency room for treatment. Additional medical information was received on 9feb17. The patient allegedly received a diagnosis of "allergic reaction" and was reportedly treated with a 7 day course of unspecified antibiotics and a topical cortisone. The reaction was reportedly resolved. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00018 |
| MDR Report Key | 6347476 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-09 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-02-21 |
| 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 | 2017-02-21 |
| Catalog Number | 3346E |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-02-21 |