DME COMPANY BECKER ORTHOPEDICS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-18 for DME COMPANY BECKER ORTHOPEDICS * manufactured by *.

Event Text Entries

[14875686] This patient came to the ed with gangrene and underwent an emergent bka (below knee amputation). Patient was quite ill and had numerous comorbidities. The patient had a bka and a stump shrinker in place that may have contributed to necrosis and harm. This resulted in advancement to an aka (above knee amputation). Md suggestion to prevent any potential problems: manufacturer should update their processes to include consulting with a patient's rn when they place an orthotic shrinker on a patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4239349
• MDR Report Key: 4239349
• Date Received: 2014-08-18
• Date of Report: 2014-08-18
• Date of Event: 2014-07-19
• Report Date: 2014-08-18
• Date Reported to FDA: 2014-08-18
• Date Reported to Mfgr: 2014-11-10
• Date Added to Maude: 2014-11-10
• 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: 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: DME COMPANY BECKER ORTHOPEDICS
• Generic Name: STOCKING, ELASTIC
• Product Code: ILG
• Date Received: 2014-08-18
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-08-18