HYDRADJUST UROLOGICAL TABLE HYDRADJUST PLUS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-10-23 for HYDRADJUST UROLOGICAL TABLE HYDRADJUST PLUS * manufactured by Liebel-flarscheim.

Event Text Entries

[210757] X-ray tube oil containment diaphram ruptured during procedure causing burn to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1518293-2001-00024
• MDR Report Key: 358066
• Report Source: 06
• Date Received: 2001-10-23
• Date of Report: 2001-10-23
• Date of Event: 2001-09-25
• Date Facility Aware: 2001-09-25
• Report Date: 2001-10-23
• Date Reported to Mfgr: 2001-09-25
• Date Mfgr Received: 2001-09-25
• Device Manufacturer Date: 1997-03-01
• Date Added to Maude: 2001-10-29
• 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: DAVID BENSON
• Manufacturer Street: *
• Manufacturer City: CINCINNATI OH 45237
• Manufacturer Country: US
• Manufacturer Postal: 45237
• Manufacturer Phone: 5139485719
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HYDRADJUST UROLOGICAL TABLE
• Generic Name: GENERAL SURGICAL TABLE
• Product Code: BWN
• Date Received: 2001-10-23
• Model Number: HYDRADJUST PLUS
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 YR
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 347276
• Manufacturer: LIEBEL-FLARSCHEIM
• Manufacturer Address: 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US
• Baseline Brand Name: HYDRADJUST UROLOGICAL TABLE
• Baseline Generic Name: GENERAL SURGICAL
• Baseline Model No: HYDRADJUST PLUS
• Baseline Catalog No: 400035
• Baseline Device Family: HYDRADJUST UROLOGICAL TABLE
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K943581
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-10-23