NEOTHERM SKIN TEMPERATURE SENSOR STS-201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-03-05 for NEOTHERM SKIN TEMPERATURE SENSOR STS-201 manufactured by Level 1, Inc..

Event Text Entries

[17903826] User alleges the wire shorted out and left black scorch marks on the outer sheath of temperature sensor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1221261-2003-00010
• MDR Report Key: 447451
• Report Source: 05,06
• Date Received: 2003-03-05
• Date of Report: 2003-02-27
• Date of Event: 2002-10-08
• Date Mfgr Received: 2002-10-08
• Date Added to Maude: 2003-03-13
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: VERNON TRIMBLE
• Manufacturer Street: 160 WEYMOUTH ST
• Manufacturer City: ROCKLAND MA 02370
• Manufacturer Country: US
• Manufacturer Postal: 02370
• Manufacturer Phone: 7818788011
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEOTHERM SKIN TEMPERATURE SENSOR
• Generic Name: SKIN TEMPERATURE SENSOR
• Product Code: KPD
• Date Received: 2003-03-05
• Returned To Mfg: 2002-10-11
• Model Number: STS-201
• Catalog Number: STS-201
• Lot Number: NI
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 436416
• Manufacturer: LEVEL 1, INC.
• Manufacturer Address: 160 WEYMOUTH ST. ROCKLAND MA 02370 US
• Baseline Brand Name: NEOTHERM SKIN TEMPERATURE SENSOR
• Baseline Generic Name: SKIN TEMPERATURE SENSOR
• Baseline Model No: STS-201
• Baseline Catalog No: STS-201
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-03-05