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

Model Number 1115

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

At the time of reporting the unit has not been made available for evaluation.

Event Description

It was reported that the mattress slid out of position during a patient transfer, leading to an unspecified injury to the caregiver.The patient was not injured as a result of the event.

Manufacturer Narrative

The investigation has been completed.During the investigation it was identified that this complaint should be for the surface rather than the stretcher.

Event Description

It was reported that the mattress slid off the litter during a patient transfer, leading to the caregiver experiencing a back strain for which they were prescribed physical therapy.The patient was not injured as a result of the event.

• Brand Name: ULTRA COMFRT, SE 4X30 DOMESTIC
• Type of Device: NON-POWERED FLOTATION THERAPY MATTRESS
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11345220
• MDR Text Key: 232445594
• Report Number: 0001831750-2021-00645
• Device Sequence Number: 1
• Product Code: IKY
• UDI-Device Identifier: 07613327278330
• UDI-Public: 07613327278330
• 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: 04/21/2021

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 Model Number: 1115
• Device Catalogue Number: 1704034300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other