MIDMARK 417-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-30 for MIDMARK 417-001 manufactured by Midmark Corp..

Event Text Entries

[5287710] User claimed while a patient was sitting on this table, the arm dropped and the patient was injured.
Patient Sequence No: 1, Text Type: D, B5

[12632270] Upon receipt of the initial call, there was limited info in regards to the injury event while utilizing this equipment. We have made numerous attempts to contact the customer for further detail of this injury, however, we have not received any further info.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2014-00019
• MDR Report Key: 4381665
• Report Source: 06
• Date Received: 2014-12-30
• Date of Report: 2014-12-30
• Date of Event: 2014-12-01
• Date Mfgr Received: 2014-12-01
• Device Manufacturer Date: 2007-03-21
• Date Added to Maude: 2015-01-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: CRAIG RAMMEL
• Manufacturer Street: 60 VISTA DR.
• Manufacturer City: VERSAILLES OH 45380
• Manufacturer Country: US
• Manufacturer Postal: 45380
• Manufacturer Phone: 8006436275
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIDMARK
• Generic Name: 417 PODIATRY EXAMINATION CHAIR
• Product Code: INQ
• Date Received: 2014-12-30
• Model Number: 417-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIDMARK CORP.
• Manufacturer Address: VERSAILLES OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-30