MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFORTGEL SE FIRE BARR 26 IN; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1805034601

Device Problem Device Slipped (1584)

Patient Problems Muscle Weakness (1967); Insufficient Information (4580)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

It was reported that the user facility has a comfortgel se surface that slid off of the stretcher when the patient was seated for a procedure to ambulate and this has led to one staff member injuring their back.Further information has not been provided at this time.

Manufacturer Narrative

It was reported that the caregiver who was injured did not miss any work for the back injury and did not seek medical treatment.It was identified during communication with the user facility that the issue of comfortgel se mattresses sliding off of the litter was likely not due to a defect with the product.The user facility stated that no further action was needed from stryker.

Event Description

It was reported that the user facility has a comfortgel se surface that slid off of the stretcher when the patient was seated for a procedure to ambulate and this has led to one staff member injuring their back.

• Brand Name: COMFORTGEL SE FIRE BARR 26 IN
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12045177
• MDR Text Key: 257731300
• Report Number: 0001831750-2021-00964
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1805034601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other