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 Injury (2348)

Event Date 10/05/2018

Event Type  Injury  

Event Description

It was reported that the mattress slid of the stretcher with a patient.It was reported that the patient was injured.It was reported that a staff member was injured when they attempted to catch the patient that slid off with the mattress.

Manufacturer Narrative

Further information regarding the alleged injuries and device use could not be provided.

Event Description

It was reported that the mattress slid of the stretcher with a patient.It was reported that the patient was injured.It was reported that a staff member was injured when they attempted to catch the patient that slid off with the mattress.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8034951
• MDR Text Key: 126013989
• Report Number: 0001831750-2018-01425
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/05/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 12/14/2018
• 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