COMFGEL SE W/O FIRE BAR, 30IN 1805034300

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 2019-01-28 for COMFGEL SE W/O FIRE BAR, 30IN 1805034300 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[134185635] This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program. The devices were 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

[134185636] This report summarizes 3 malfunction events, where it was reported the mattress slipped off the stretcher. There was patient involvement, however there were no consequences or impacts to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2019-00071
• MDR Report Key: 8280801
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-01-28
• Date of Report: 2019-01-28
• Date of Event: 2018-10-01
• Date Mfgr Received: 2019-01-01
• Date Added to Maude: 2019-01-28
• 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. MARY KLAVER
• 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: COMFGEL SE W/O FIRE BAR, 30IN
• Generic Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Product Code: IKY
• Date Received: 2019-01-28
• Catalog Number: 1805034300
• 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		2019-01-28