RULER 71674079

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for RULER 71674079 manufactured by Smith & Nephew, Inc..

Event Text Entries

[137432055]
Patient Sequence No: 1, Text Type: N, H10

[137432056] It was reported that during surgery the threaded portion was broken. No delay or injury reported. A back up device was available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020279-2019-00874
• MDR Report Key: 8378722
• Date Received: 2019-02-28
• Date of Report: 2019-03-19
• Date of Event: 2019-02-07
• Date Mfgr Received: 2019-02-07
• Date Added to Maude: 2019-02-28
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. SARAH FREESTONE
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 0447940038
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RULER
• Generic Name: TAPE, MEASURING, RULERS AND CALIPERS
• Product Code: FTY
• Date Received: 2019-02-28
• Catalog Number: 71674079
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-28