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

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 10/29/2018

Event Type  Injury  

Event Description

It was reported a patient was admitted with a pressure injury on the buttock, but the facility believed the wound had worsened while the patient was on the surface.

Manufacturer Narrative

An rn from the account confirmed from the patient's file that the patient had not been admitted for a pressure injury.She stated the patient had been on the mattress for 3 days and per their hospital's protocols, was being turned every 2 hours.The nurse stated they had noticed a small imprint on the patient's skin in the morning of the 3rd day, which looked to be slightly more prominent in the evening.She further reported that the patient's skin scored a 15 on the braden scale, putting the patient at risk for injury which may have contributed to the issue.The nurse stated they will be more diligent on checking the patient's skin in the future.No product malfunction was alleged.It was confirmed the account required no further action from stryker.Serial number of the unit was not recorded.

Event Description

It was reported a patient was admitted with a pressure injury on the buttock, but the facility believed the wound had worsened while the patient was on the surface.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8108488
• MDR Text Key: 128560463
• Report Number: 0001831750-2018-01444
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 02/01/2019

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 02/01/2019
• 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