RENAISSANCE 29 OBS 10/25/04 1710 1710000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-01-09 for RENAISSANCE 29 OBS 10/25/04 1710 1710000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[3110510] It was reported by service report that the brakes could not be engaged.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2013-00012
• MDR Report Key: 2903301
• Report Source: 00
• Date Received: 2013-01-09
• Date of Report: 2012-12-19
• Date of Event: 2012-12-19
• Date Mfgr Received: 2012-12-19
• Device Manufacturer Date: 1995-08-01
• Date Added to Maude: 2013-03-14
• 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: MR. ANTHONY NOORA
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal: 49002
• Manufacturer Phone: 2693292100
• Manufacturer G1: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• 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: RENAISSANCE 29 OBS 10/25/04
• Generic Name: DEVICE, TRANSFER, PATIENT, MANUAL
• Product Code: FMR
• Date Received: 2013-01-09
• Model Number: 1710
• Catalog Number: 1710000000
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Address: 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-01-09