FROG LEGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-03-02 for FROG LEGS manufactured by Na.

Event Text Entries

[309158] Frog legs, manufactured by frog legs, inc. , are a specialized type of shock absorbing front caster assembly for a wheelchair. Frog legs are attached to a tilite zra wheelchair using a stem bolt. Because the front casters on a wheelchair are subject to high stresses in daily wheelchair use, the specifications for the stem bolt call for it to be manufactured from 4140 steel. This type of steel is specified because of its high tensile strength and elasticity in order to ensure that it will bend but not break under high stress. Tisport, llc and frog legs, inc. Have determined that the supplier who manufactured the stem bolts did not mfr them to the specifications given to such mfr by frog legs, inc. Specifically, the mfr was supposed to use 4140 steel but mistakenly used 1144 stressproof steel, which is less elastic than 4140 steel. As a result of the improper mfr of the stem bolts, the stem bolts broke on the frog legs on the wheelchair manufactured for the pt. Frog legs, inc. Has notified all purchasers of tilite zra wheelchairs with frog legs that the stem bolts could break and is in the process of obtaining replacement stem bolts made to the correct specifications. Tilite has ceased all shipments of new tilite zra products with frog legs until it receives the new stem bolts.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1934422-2004-00001
• MDR Report Key: 516400
• Report Source: 00
• Date Received: 2004-03-02
• Date of Report: 2004-02-26
• Date Mfgr Received: 2004-02-26
• Date Added to Maude: 2004-03-19
• 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: 0
• Manufacturer Street: 500 EAST 6TH STREET
• Manufacturer City: VINTON IA 52349
• Manufacturer Country: US
• Manufacturer Postal: 52349
• Manufacturer Phone: 3194724972
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FROG LEGS
• Generic Name: NA
• Product Code: KNO
• Date Received: 2004-03-02
• Model Number: NA
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 505424
• Manufacturer: NA
• Manufacturer Address: NA NA *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-03-02