MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFGEL SE W/O FIRE BAR, 30IN; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1805034300

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2017

Event Type  malfunction  

Event Description

It was reported that the patient was getting off the side of the unit and the mattress slid off the litter.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the patient was getting off the side of the unit and the mattress slid off the litter.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: COMFGEL SE W/O FIRE BAR, 30IN
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6949757
• MDR Text Key: 89860197
• Report Number: 0001831750-2017-00452
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1805034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1