MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFRT, SE 4X30 DOMESTIC; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034300

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

It was reported that a nurse was helping a patient when the mattress slid.The nurse was reported to have suffered a knee injury as a result.The patient was not injured as a result of the event.

Event Description

It was reported that a nurse was helping a patient when the mattress slid.The nurse was reported to have suffered a knee injury as a result.The nurse did not seek medical treatment or time off work as a result of the injury.The patient was not injured as a result of the event.

Manufacturer Narrative

The investigation has been completed.The completed investigation identified that this incident resulted in a minor rather than serious injury.The b5 summary and section h codes have been updated to reflect this.

• Brand Name: ULTRA COMFRT, SE 4X30 DOMESTIC
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11561060
• MDR Text Key: 241975516
• Report Number: 0001831750-2021-00667
• 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: 06/16/2021

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: 1704034300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other