7684 LA NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-11-17 for 7684 LA NA manufactured by Nellcor Puritan Bennett.

Event Text Entries

[19234521] Event description reported to mfr by customer. Customer reports having trouble getting the platform to deploy all the way flat, and the end barriers to work properly. In one incident last february, user was exiting the van, when he reached the ground and tried to exit from the platform he realized that he was somehow hungup on the end barrier. It was very dark out and he could not see exactly what he was caught on. He once again attempted to move forward, when suddenly his leg flew up and his shoe flew off. He requested assistance from his wife to get his foot back on the foot rest. When she came to assist she noticed that he was bleeding badly from the end of his foot. She performed first aid and took him to the hosp. The incident resulted in a crush injury to his big toe and an amputation of his third toe from the second knuckle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183897-1997-00008
• MDR Report Key: 134011
• Report Source: 04
• Date Received: 1997-11-17
• Date of Report: 1997-10-16
• Date of Event: 1997-02-01
• Date Mfgr Received: 1997-10-16
• Date Added to Maude: 1997-11-25
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 7684 LA
• Generic Name: AUTOMATIC VAN LIFT
• Product Code: ING
• Date Received: 1997-11-17
• Model Number: 7684 LA
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: UNKNOWN
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 130972
• Manufacturer: NELLCOR PURITAN BENNETT
• Manufacturer Address: 14800 28TH AVE NORTH PLYMOUTH MN 55447 US
• Baseline Brand Name: 7684 LA
• Baseline Generic Name: AUTOMATIC VAN LIFT
• Baseline Model No: 7684 LA
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-11-17