MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 3 X 30; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1703034300

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the nurse tore their meniscus or ligament requiring treatment.Device could not be identified.

Event Description

It was reported that while transferring a (b)(6) patient from a stretcher with the mattress to an ambulance cot for transport to another facility.The mattress moved with the patient and both began to slide off.One of the nurses went to catch the patient and "tweaked" their knee.

Manufacturer Narrative

Added the serial number and updated the result and conclusion code.

Event Description

It was reported that while transferring a 360lb patient from a stretcher with the mattress to an ambulance cot for transport to another facility.The mattress moved with the patient and both began to slide off.One of the nurses went to catch the patient and "tweaked" their knee.

• Brand Name: ULTRA COMFORT, SE 3 X 30
• 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: 8355981
• MDR Text Key: 136716029
• Report Number: 0001831750-2019-00270
• 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: 03/12/2019

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: 1703034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 03/12/2019
• 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