MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUSHION ASSY SPR-PLUS BOX OF 6; BED, FLOTATION THERAPY, POWERED

Model Number 2790

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Actual device not identified.

Event Description

It was reported that a pressure injury occurred and it was later discovered that the mattress overlay was defective.Further information has not been provided.

Manufacturer Narrative

It was alleged that the overlay developed a leak, and a patient's stage 2 pressure injury progressed to a stage 3 pressure injury.It was reported that the patient presented with a stage 2 pressure injury on admission, which was treated with appropriate dressing and the overlay with a turn schedule.The overlay was alleged to have a leak and upon reassessment of the wound, the wound had progressed to a shallow stage 3 pressure injury.The overlay was discarded, an evaluation was not performed and the lot number could not be identified.H3 other text: device discarded.

Event Description

It was reported that a pressure injury occurred and it was reported that the mattress overlay was defective.

• Brand Name: CUSHION ASSY SPR-PLUS BOX OF 6
• Type of Device: BED, FLOTATION THERAPY, 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: 16601550
• MDR Text Key: 311929362
• Report Number: 0001831750-2023-00318
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 07613327175042
• UDI-Public: 07613327175042
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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 Model Number: 2790
• Device Catalogue Number: 2790100000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other