TECNOL * 18686-010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-05 for TECNOL * 18686-010 manufactured by Tecnol, Inc..

Event Text Entries

[32277] Husband reports strap of arm board caught around 2nd and 3rd digit lt hand tightly. Reports fingers purple and reapplied around palm. 7 days later, pt required amputation of lt 2nd digit, proximal inter-phalange.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 53472
• MDR Report Key: 53472
• Date Received: 1996-12-05
• Date of Report: 1996-12-05
• Date of Event: 1996-11-08
• Date Facility Aware: 1996-11-13
• Report Date: 1996-12-05
• Date Reported to FDA: 1996-12-05
• Date Reported to Mfgr: 1996-12-05
• Date Added to Maude: 1996-12-06
• 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
• Reporter Occupation: RISK MANAGER
• 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: TECNOL
• Generic Name: ARM BOARD FOR IV USE
• Product Code: BTX
• Date Received: 1996-12-05
• Model Number: *
• Catalog Number: 18686-010
• Lot Number: *
• ID Number: US PAT # 40798,199
• Operator: UNKNOWN
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 54083
• Manufacturer: TECNOL, INC.
• Manufacturer Address: 7201 INDUSTRIAL PARK BLVD FORT WORTH TX 76180 US
• Baseline Brand Name: ADULT ARTERIAL HAND-AID WRIST SUPPORT
• Baseline Generic Name: I.V. SUPPORT
• Baseline Model No: NA
• Baseline Catalog No: 18686-010
• Baseline ID: NA
• Baseline Device Family: I.V. THERAPY PRODUCTS
• Baseline Shelf Life Contained: A
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K820038
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-12-05