TRAUMA IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-11-28 for TRAUMA IMPLANT manufactured by Smith & Nephew, Inc..

Event Text Entries

[168432095] It was reported that the patient participated in a (b)(6) study, after surgery the patient developed infection and needed surgical debridement.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020279-2019-04194
• MDR Report Key: 9390496
• Report Source: FOREIGN,HEALTH PROFESSIONAL,L
• Date Received: 2019-11-28
• Date of Report: 2019-11-28
• Date Mfgr Received: 2019-11-06
• Date Added to Maude: 2019-11-28
• 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
• 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: TRAUMA IMPLANT
• Generic Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Product Code: MDM
• Date Received: 2019-11-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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	1. Hospitalization; 2. Required No Informationntervention	2019-11-28