MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. BCI® DISPOSABLE SENSORS; OXIMETER

Catalog Number	1303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient sustained a burn (redness) while using a bci® disposable sensor.The patient was taken to the hospital (could have been for something else).The doctor informed the mom that the burn could have been due to the probe.The patient was treated with venelex ointment for a deep tissue wound on left big toe, burn mark on right foot, and burn on side of foot.Venelex ointment is used to promote wound healing.No other adverse events reported.

• Brand Name: BCI® DISPOSABLE SENSORS
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7072414
• Report Number: 3012307300-2017-02471
• Device Sequence Number: 1159262
• Product Code: DQA
• UDI-Device Identifier: 15019517042511
• UDI-Public: 15019517042511
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K920082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1303
• Device Lot Number: 1717-5
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO