CAVILON NO STING BARRIER FILM 1ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for CAVILON NO STING BARRIER FILM 1ML manufactured by 3m.

Event Text Entries

[95772391] The physical therapy assistant (pta) was at the home providing pt services to the patient. The patient requires the use of kiniesotape as part of the treatment plan. To ensure long term application and prevent the kiniesotape from falling off the ptra applies skin prep prior to application. At this visit prior to kiniesotape application the pta opened the skin prep and touched the patient at which time an "electric shock" occurred which then ignited a fire and the patient caught on fire. The pta was able to put the fire but the patient did suffer injury as a result of the event. The injury includes: second degree burn to the posterior right le at the ankle region; 1st degree burn on the rle the patient also has damage to his home with burn marks on the carpet. Pt does not smoke and there was no oxygen in the home. There was no fire (candles etc. ) in the home. We did report the problem to 3m; pt is now receiving nursing care for wound care in the home; the 2nd degree burn is being treated with silvadene cream. Therapy dates: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7145730
• MDR Report Key: 7145730
• Date Received: 2017-12-22
• Date Added to Maude: 2017-12-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CAVILON NO STING BARRIER FILM 1ML
• Generic Name: CAVILON NO STING BARRIER FILM 1ML
• Product Code: KMF
• Date Received: 2017-12-22
• Lot Number: 2020-05 GA
• ID Number: NDC # 3344
• Device Availability: *
• Device Age: 1 YR
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: 3M

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2017-12-22