UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-11 for UNK * manufactured by *.

Event Text Entries

[347596] Pt using parallel bars in physical therapy when left bar suddenly dropped. Pt experienced sudden bend forward and to the left without falling. Pt reported new incidence of pain in low back. Back spasms when transferring to w/c. Denies numbness or tingling in back or legs. Evaluated in er.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 572689
• MDR Report Key: 572689
• Date Received: 2005-02-11
• Date of Report: 2005-01-28
• Date of Event: 2005-01-26
• Date Facility Aware: 2005-01-26
• Report Date: 2005-01-28
• Date Added to Maude: 2005-02-15
• 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: 3
• 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: UNK
• Generic Name: PARALLEL BAR
• Product Code: ILZ
• Date Received: 2005-02-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 562557
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-11