ULTRA COMFORT, SE 3 X 30 INTL 1703034301

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 2020-01-28 for ULTRA COMFORT, SE 3 X 30 INTL 1703034301 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[176868007] This mdr is part of the fda voluntary malfunction summary reporting program. Six devices were evaluated in the field but the issue was not confirmed; no defect or malfunction was found. Five devices were not made available for testing by the customer; no cause was established. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10

[176868008] This report summarizes 11 malfunction events, where it was reported the mattress slipped off. There was one instance of patient involvement where it was reported the patient fell, but there were no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2020-00280
• MDR Report Key: 9638782
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-01-28
• Date of Report: 2020-01-28
• Date of Event: 2020-01-01
• Date Mfgr Received: 2020-01-01
• Date Added to Maude: 2020-01-28
• 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 COMFORT, SE 3 X 30 INTL
• Generic Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Product Code: IKY
• Date Received: 2020-01-28
• Catalog Number: 1703034301
• 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		2020-01-28