PORTALCAST 1210 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-07 for PORTALCAST 1210 * manufactured by Diacor, Inc..

Event Text Entries

[162182] Failure of particle board mount for hydraulic mold clamp system. The particle board broke allowing hydraulic clamp to push up. This caused the alloy melting pot on the shelf above to tilt precariously. The particle board was reinforced with steel plate to prevent future recurrence.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017886
• MDR Report Key: 257891
• Date Received: 2000-01-07
• Date of Report: 2000-01-06
• Date of Event: 2000-01-04
• Date Added to Maude: 2000-01-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PORTALCAST
• Generic Name: MOLD CUTTING AND BLOCK FABRICATION SYSTEM
• Product Code: IXI
• Date Received: 2000-01-07
• Model Number: 1210
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 249734
• Manufacturer: DIACOR, INC.
• Manufacturer Address: 3191 SOUTH 3300 EAST SUITE 100-A SALT LAKE CITY UT 84109 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-01-07