* 3820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-09-15 for * 3820 manufactured by Zimmer Patient Care.

Event Text Entries

[182753] Cast cart turned over on employee.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1035617-2000-00004
• MDR Report Key: 296800
• Report Source: 05,06
• Date Received: 2000-09-15
• Date of Report: 2000-08-25
• Date of Event: 2000-08-18
• Date Facility Aware: 2000-08-18
• Report Date: 2000-08-25
• Date Reported to FDA: 2000-08-25
• Date Reported to Mfgr: 2000-08-25
• Date Added to Maude: 2000-09-21
• 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: PAULA OSORIO
• Manufacturer Street: 200 W OHIO AVE
• Manufacturer City: DOVER OH 44622
• Manufacturer Country: US
• Manufacturer Postal: 44622
• Manufacturer Phone: 3303649483
• 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: *
• Generic Name: CAST CART
• Product Code: LFG
• Date Received: 2000-09-15
• Model Number: 3820
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NO INFO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 283596
• Manufacturer: ZIMMER PATIENT CARE
• Manufacturer Address: P.0. BOX 5217 STATESVILLE NC 28687 US
• Baseline Brand Name: ZIMMER CAST CART
• Baseline Generic Name: CAST CART
• Baseline Model No: NA
• Baseline Catalog No: 3820
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-09-15