ULTRA COMFRT, SE 4X30 DOMESTIC 1704034300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-27 for ULTRA COMFRT, SE 4X30 DOMESTIC 1704034300 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[176999151] This mdr is part of the fda voluntary malfunction summary reporting program. The device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10

[176999152] This report summarizes 1 malfunction event, where it was reported the mattress slipped off. There was patient involvement; no adverse consequences or clinically significant delay were reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2020-00131
• MDR Report Key: 9634062
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-01-27
• Date of Report: 2020-01-27
• Date of Event: 2020-01-01
• Date Mfgr Received: 2020-01-01
• Date Added to Maude: 2020-01-27
• 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: 3
• Event Location: 3
• Manufacturer Contact: MR. KRISTEN CANTER
• 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: ULTRA COMFRT, SE 4X30 DOMESTIC
• Generic Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Product Code: IKY
• Date Received: 2020-01-27
• Catalog Number: 1704034300
• 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		2020-01-27