STYLE 100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-28 for STYLE 100 manufactured by Redline Wheel Chair.

Event Text Entries

[16142863] Resident had been taken out of whirlpool and sat into the wheelchair to be dressed. Resident hit her leg on lower part of wheelchair where leg support attaches. Resident lacerated the left lower leg, approximately 2 1/2 inches. Resident was taken to the hospital and seen by a physician 7 sutures were given with pressure dressing applied and medication prescribed. Device labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8998
• MDR Report Key: 8998
• Date Received: 1994-03-28
• Date of Report: 1994-03-01
• Date of Event: 1993-11-15
• Date Facility Aware: 1993-11-15
• Report Date: 1994-03-01
• Date Reported to FDA: 1994-03-01
• Date Added to Maude: 1994-11-08
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: WHEELCHAIR
• Product Code: IMM
• Date Received: 1994-03-28
• Model Number: STYLE 100
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8658
• Manufacturer: REDLINE WHEEL CHAIR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-03-28