SADDLE ABDUCTER WEDGE, BRACE LATERAL AND PELVIC POSITIONER N/I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for SADDLE ABDUCTER WEDGE, BRACE LATERAL AND PELVIC POSITIONER N/I manufactured by Health Care Provider.

Event Text Entries

[17799434] Resident using seating device tipped forward causing laceration on forehead requiring sutures. Elbow developed cellulitisdevice labeled for single use. Patient medical status prior to event: fair condition. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device use continued with restrictions/limitations, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1093
• MDR Report Key: 1093
• Date Received: 1992-07-22
• Date of Event: 1992-03-07
• Date Facility Aware: 1992-03-07
• Date Reported to Mfgr: 1992-03-20
• Date Added to Maude: 1992-08-20
• 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

• Brand Name: SADDLE ABDUCTER WEDGE, BRACE LATERAL AND PELVIC POSITIONER
• Generic Name: SAME AS ABOVE
• Product Code: ITC
• Date Received: 1992-07-22
• Model Number: N/I
• Catalog Number: N/I
• Lot Number: N/I
• ID Number: N/I
• Operator: OTHER
• Device Availability: *
• Device Age: 01-FEB-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1047
• Manufacturer: HEALTH CARE PROVIDER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-22