PERSONAL BACK PLUS PPM18T *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-03 for PERSONAL BACK PLUS PPM18T * manufactured by Invacare Corp..

Event Text Entries

[21035016] Back of resident's wheelchair fell off. Resident fell backwards out of chair. Stated she hit her hed. Nursing staff turned the wrong way. Dr's office was notified. In evening of date of event the daughter spoke with her mother. Resident stated her neck was hurting.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010873
• MDR Report Key: 73120
• Date Received: 1997-03-03
• Date of Report: 1997-02-19
• Date of Event: 1997-02-03
• Date Added to Maude: 1997-03-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OCCUPATIONAL THERAPIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERSONAL BACK PLUS
• Generic Name: BACK SUPPORT FOR WHEELCHAIR
• Product Code: IMS
• Date Received: 1997-03-03
• Model Number: PPM18T
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 72962
• Manufacturer: INVACARE CORP.
• Manufacturer Address: 899 CLEVELAND ST ELYRIA OH 440364028 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-03-03