KNEE LENGTH SUPPORT 59110101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2003-04-11 for KNEE LENGTH SUPPORT 59110101 manufactured by Smith & Nephew Inc., Wound Management Divison.

Event Text Entries

[16396869] Burn compression garments used for both feet caused blisters to form at base of both little toes and cut into instep area, causing additional scarring.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1017593-2003-00001
• MDR Report Key: 453171
• Report Source: 00,05
• Date Received: 2003-04-11
• Date of Report: 2003-03-17
• Date of Event: 2003-03-14
• Date Mfgr Received: 2003-03-14
• Date Added to Maude: 2003-04-15
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JIM IRVIN, VP
• Manufacturer Street: 11775 STARKEY ROAD PO BOX 1970
• Manufacturer City: LARGO FL 337734727
• Manufacturer Country: US
• Manufacturer Postal: 337734727
• Manufacturer Phone: 7273921261
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KNEE LENGTH SUPPORT
• Generic Name: JOBSKIN
• Product Code: DWL
• Date Received: 2003-04-11
• Model Number: NA
• Catalog Number: 59110101
• Lot Number: 3513264
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 442169
• Manufacturer: SMITH & NEPHEW INC., WOUND MANAGEMENT DIVISON
• Manufacturer Address: 11775 STARKEY ROAD PO BOX 1970 LARGO FL 337734727 US
• Baseline Brand Name: KNEE LENGTH SUPPORT
• Baseline Generic Name: JOBSKIN
• Baseline Model No: NA
• Baseline Catalog No: 59110101
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-04-11