AMSCO 56130001 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-04 for AMSCO 56130001 * manufactured by Amsco.

Event Text Entries

[18950236] During procedure, the right armboard fell off the bed. Pt's arm was supported by a physician until a replacement armboard was attached to the bed. Although no initial injury was evident, the pt sustained iv infiltration resulting in subsequent surgical intervention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 147749
• MDR Report Key: 147749
• Date Received: 1998-02-04
• Date of Report: 1998-02-02
• Date of Event: 1998-01-27
• Date Facility Aware: 1998-01-27
• Report Date: 1998-02-02
• Date Reported to FDA: 1998-02-02
• Date Reported to Mfgr: 1998-02-02
• Date Added to Maude: 1998-02-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMSCO
• Generic Name: ARMBOARD
• Product Code: FSE
• Date Received: 1998-02-04
• Model Number: 56130001
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 143974
• Manufacturer: AMSCO
• Manufacturer Address: PO BOX 83069 RICHARDSON TX 73083 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	1998-02-04