EXOGEN 71034100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-16 for EXOGEN 71034100 manufactured by Smith & Nephew Orthopaedics.

Event Text Entries

[1914524] It has been reported that patient developed a severe rash while using the exogen unit.
Patient Sequence No: 1, Text Type: D, B5

[8833432] .
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2011-00080
• MDR Report Key: 2020322
• Report Source: 07
• Date Received: 2011-03-16
• Date of Report: 2011-03-16
• Date of Event: 2010-10-01
• Date Mfgr Received: 2011-03-11
• Device Manufacturer Date: 2010-07-01
• Date Added to Maude: 2011-03-17
• 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: 0
• Event Location: 0
• Manufacturer Contact: MS. CONNIE BOANE
• Manufacturer Street: 1450 E. BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013995985
• Manufacturer G1: SMITH & NEPHEW ORTHOPAEDICS
• 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: EXOGEN
• Generic Name: BONE GROWTH STIMULATOR
• Product Code: LPQ
• Date Received: 2011-03-16
• Catalog Number: 71034100
• Lot Number: 0710035470E
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW ORTHOPAEDICS
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-03-16