MIDMARK 647-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-11-02 for MIDMARK 647-001 manufactured by Midmark Corp..

Event Text Entries

[3048959] Male patient scratched his forearm on patient right hand side arm pad.
Patient Sequence No: 1, Text Type: D, B5

[10296463] The staples holding the vinyl to the arm board were too long and not to specifications. This allowed part of the staple to exit the side of the arm board into the foam padding. Over time the vinyl wore to the point that the end of the staple was able to contact the facility staff.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1523530-2012-00028
• MDR Report Key: 2844836
• Report Source: 06,07
• Date Received: 2012-11-02
• Date of Report: 2012-11-01
• Date of Event: 2012-10-03
• Date Mfgr Received: 2012-10-03
• Device Manufacturer Date: 2010-07-01
• Date Added to Maude: 2013-02-12
• 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: 9375263662
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIDMARK
• Generic Name: CHAIR, SURGICAL, AC-POWERED
• Product Code: GBB
• Date Received: 2012-11-02
• Returned To Mfg: 2012-10-17
• Model Number: 647-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• 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		2012-11-02