MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO OVERLAY SOFCARE; BED, FLOTATION THERAPY, POWERED

Catalog Number 2890030400

Device Problems Decrease in Pressure (1490); Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 12/13/2021

Event Type  Injury  

Event Description

It was reported that one of the air bladders ruptured, making the surface uneven.It was further reported that a patient developed a pressure ulcer; however, the user facility did not provide details as to what contributed to the pressure injury.An investigation is currently ongoing to gather more information regarding the pressure injury.

Manufacturer Narrative

The b5 summary and section h codes have been updated to reflect the completed investigation.

Event Description

It was reported that one of the air bladders ruptured, making the surface uneven.It was further reported that a patient developed a pressure ulcer; however, the user facility did not provide details as to what contributed to the pressure injury.

• Brand Name: OVERLAY SOFCARE
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13044737
• MDR Text Key: 282510913
• Report Number: 0001831750-2021-01653
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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 Catalogue Number: 2890030400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 03/29/2022
• 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
• Patient Outcome(s): Other