INTEGRA LUXTEC MLX LIGHT SOURCE BOX 00MLX NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for INTEGRA LUXTEC MLX LIGHT SOURCE BOX 00MLX NA manufactured by Integra Lifesciences Corporation.

Event Text Entries

[181629396] Pt sustained burn to left thigh after ureteral lighted stents were taped to left thigh. The portable light box was used to connect the ureteral lighted stents.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093319
• MDR Report Key: 9763662
• Date Received: 2020-02-26
• Date of Report: 2020-01-29
• Date of Event: 2020-01-29
• Date Added to Maude: 2020-02-27
• Event Key: 0
• Report Source Code: Voluntary 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 Sequence Number: 1

• Brand Name: INTEGRA LUXTEC MLX LIGHT SOURCE BOX
• Generic Name: LIGHTSOURCE, FIBEROPTIC, ROUTINE
• Product Code: FCW
• Date Received: 2020-02-26
• Model Number: 00MLX
• Catalog Number: NA
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES CORPORATION
• Manufacturer Address: PLAINSBORO NJ US

Device Sequence Number: 2

• Brand Name: KARL STORZ LIGHTED URETERAL STENT
• Generic Name: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• Product Code: FCS
• Date Received: 2020-02-26
• Model Number: NA
• Catalog Number: NA
• Lot Number: PQ01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: KARL STORZ

Device Sequence Number: 3

• Brand Name: KARL STORZ LIGHT CORD
• Generic Name: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• Product Code: FCS
• Date Received: 2020-02-26
• Lot Number: ZT26
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOVISION INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-26