MOBILE TREAT. REC. LY5007 3300000020 NA

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 2010-07-28 for MOBILE TREAT. REC. LY5007 3300000020 NA manufactured by Stryker Corp, Medical Division.

Event Text Entries

[1632412] It has been alleged that the bottom of the frame broke in half.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1831750-2010-01665
• MDR Report Key: 1787880
• Report Source: 06
• Date Received: 2010-07-28
• Date of Report: 2010-07-01
• Date of Event: 2010-06-30
• Date Mfgr Received: 2010-07-01
• Device Manufacturer Date: 2007-08-28
• Date Added to Maude: 2010-09-23
• 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: RENATA SILA
• Manufacturer Street: 3800 E. CENTRE AVE.
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal: 49002
• Manufacturer Phone: 2693246689
• Manufacturer G1: STRYKER MEDICAL KALAMAZOO
• Manufacturer Street: 3800 E. CENTRE AVE.
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal Code: 49002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MOBILE TREAT. REC. LY5007
• Generic Name: EXAMINATION AND TREATMENT CHAIR
• Product Code: ETF
• Date Received: 2010-07-28
• Model Number: 3300000020
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER CORP, MEDICAL DIVISION
• Manufacturer Address: PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-07-28