* 88-9760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-27 for * 88-9760 manufactured by Carefusion 2200, Inc..

Event Text Entries

[18624441] A tebbetts lighted breast retractor was being used during breast surgery. The light source, a luxtex mlx by integra, was running with the light source at 100%. Throughout the case, the retractor was moved from the mayo stand onto the patient's direct skin. An approximately 4 cm burn developed inferior to the right breast, appearing light pink in color. Ointment and a wound dressing were applied to the area. During a follow-up clinic appointment, another would dressing was applied.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3649570
• MDR Report Key: 3649570
• Date Received: 2013-12-27
• Date of Event: 2013-12-05
• Date Added to Maude: 2014-02-27
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: LIGHT CABLE
• Product Code: FTA
• Date Received: 2013-12-27
• Model Number: *
• Catalog Number: 88-9760
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAREFUSION 2200, INC.
• Manufacturer Address: 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061

Device Sequence Number: 2

• Brand Name: SNOWDEN-PENCER TEBBETTS
• Generic Name: RETRACTOR, FIBEROPTIC
• Product Code: FDG
• Date Received: 2013-12-27
• Model Number: *
• Catalog Number: 88-1087
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CAREFUSION 2200, INC.
• Manufacturer Address: 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061

Device Sequence Number: 3

• Brand Name: SNOWDEN-PENCER TEBBETTS
• Generic Name: RETRACTOR, FIBEROPTIC
• Product Code: GAD
• Date Received: 2013-12-27
• Model Number: *
• Catalog Number: 88-1088
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CAREFUSION 2200, INC.
• Manufacturer Address: 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061

Device Sequence Number: 4

• Brand Name: SNOWDEN-PENCER TEBBETTS
• Generic Name: RETRACTOR, FIBEROPTIC
• Product Code: GAD
• Date Received: 2013-12-27
• Model Number: *
• Catalog Number: 88-1090
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CAREFUSION 2200, INC.
• Manufacturer Address: 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-27