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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-19 for * manufactured by Carestream Health, Inc..

Event Text Entries

[15811203] The patient sustained a displaced volar plate fracture at the base of the third distal phalanx when the tabletop was moved appropriately at the completion of the exam. The design of the table does not provide for hand safety during expected movement of the table. Optional hand grips are available but still do not fully protect the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4205656
• MDR Report Key: 4205656
• Date Received: 2014-08-19
• Date of Report: 2014-08-19
• Date of Event: 2014-07-07
• Report Date: 2014-08-19
• Date Reported to FDA: 2014-08-19
• Date Reported to Mfgr: 2014-10-28
• Date Added to Maude: 2014-10-28
• 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: *
• Generic Name: RADIOGRAPHIC TABLE
• Product Code: IXQ
• Date Received: 2014-08-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARESTREAM HEALTH, INC.
• Manufacturer Address: 1049 WEST RIDGE ROAD ROCHESTER NY 14615 US 14615

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-08-19