MIDMARK 153592

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 2014-10-31 for MIDMARK 153592 manufactured by Midmark Corp..

Event Text Entries

[5035204] Patient have been getting their legs caught between the chairs seat and armrest. Injury described as compression with no broken bones or lacerations.
Patient Sequence No: 1, Text Type: D, B5

[12564426] The midmark ultra chair movement is controlled by the operator. Patients are transitioning into a non-seated position while the chair is moving. This was explained to the end user.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2014-00017
• MDR Report Key: 4264886
• Report Source: 06
• Date Received: 2014-10-31
• Date of Report: 2014-10-31
• Date of Event: 2014-10-02
• Date Mfgr Received: 2014-10-02
• Device Manufacturer Date: 2011-03-01
• Date Added to Maude: 2014-11-21
• 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: 3
• 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: 9375268428
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIDMARK
• Generic Name: CHAIR, DENTAL, WITHOUT OPERATIVE UNI
• Product Code: NRU
• Date Received: 2014-10-31
• Model Number: 153592
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIDMARK CORP.
• Manufacturer Address: VERSAILLES OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-10-31