CLEAR LAP TRAY, NO EDGES 31163/8242 31163

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-27 for CLEAR LAP TRAY, NO EDGES 31163/8242 31163 manufactured by Therafin Corporation.

Event Text Entries

[7587] On 10/18/93 at 1645, resident was sitting up in a wheelchair with a lap tray in place, when resident fell to floor. Resident suffered two (2) lacerations on mid-forehead and bridge of nose, and fractured nasal bone and maxillary spine. It was noted that the velcro strap at right side of lap tray had loosened and given way, causing the whole lap trap to loosen, which subsequently led to residents fall. It was found that athe lap tray was applied properly. It was suspected there was not enough surface velcro for adherence and any pressure against the strap loosened the velcro for adhesion. All lap trays of this type were removed from use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1218386-1993-00001
• MDR Report Key: 11480
• Date Received: 1993-12-27
• Date of Report: 1993-11-03
• Date of Event: 1993-10-18
• Date Facility Aware: 1993-10-27
• Report Date: 1993-11-03
• Date Reported to FDA: 1993-11-03
• Date Reported to Mfgr: 1993-11-03
• Date Added to Maude: 1994-02-16
• Event Key: 0
• Report Source Code: Distributor 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: 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: CLEAR LAP TRAY, NO EDGES
• Generic Name: WHEELCHAIR LAP TRAY
• Product Code: IMX
• Date Received: 1993-12-27
• Model Number: 31163/8242
• Catalog Number: 31163
• Lot Number: N/A
• ID Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 MO
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 11480
• Manufacturer: THERAFIN CORPORATION
• Manufacturer Address: 19747 WOLF ROAD P.O. BOX 848 MOKENA IL 60448 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-12-27