OPERON B710 OT-160-1075

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 2006-02-21 for OPERON B710 OT-160-1075 manufactured by Berchtold Corp..

Event Text Entries

[453034] The surgical table tipped during a procedure. The staff supported the table when it tipped and no pt injuries were reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220685-2006-00001
• MDR Report Key: 679937
• Report Source: 06
• Date Received: 2006-02-21
• Date of Report: 2006-02-17
• Date of Event: 2006-01-31
• Device Manufacturer Date: 2004-10-01
• Date Added to Maude: 2006-03-01
• 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 Contact: JAY UPCHURCH
• Manufacturer Street: 1950 HANAHAN RD
• Manufacturer City: CHARLESTON SC 29406
• Manufacturer Country: US
• Manufacturer Postal: 29406
• Manufacturer Phone: 8435696100
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPERON
• Generic Name: SURGICAL TABLE
• Product Code: FWY
• Date Received: 2006-02-21
• Model Number: B710
• Catalog Number: OT-160-1075
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 669213
• Manufacturer: BERCHTOLD CORP.
• Manufacturer Address: * CHARLESTON SC * US
• Baseline Brand Name: OPERON
• Baseline Generic Name: SUROICAL TABLE
• Baseline Model No: B710
• Baseline Catalog No: OT-160-1075
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-02-21