MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. VELARIS MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Dent in Material (2526)

Patient Problem Tissue Breakdown (2681)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Once the investigation results are available a supplemental report will be submitted.H3 other text : mattress not tagged by the customer for evaluation.

Event Description

We have received information from one customer that their patients sustained serious injuries while using an arjo mattress.There are 9 cases of serious skin breakdown, which occurred in different locations of patients bodies.This is report number 1 of 9 that will be submitted.The customer alleged that the mattresses had a dip or there was a sensation of a hard surface.The customer placed the mattresses into circulation and they are still used by the patients.These are mattresses built of foam, which responds to the patient¿s weight and patient¿s are supported on this foam.The investigation into the alleged dip in the center of the mattress is ongoing.This report is fulfilled taking a conservative approach, following the serious injury reported.

Manufacturer Narrative

A female patient sustained a stage 4 pressure injury to right ear while on velaris mattress.However, these injuries were not related to arjo product per the customer, but were caused by external devices.The investigation is ongoing, the gathered data are analyzed.When conclusion is reached from the data, a supplemental report will be provided.

• Brand Name: VELARIS MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18667056
• MDR Text Key: 334845470
• Report Number: 3007420694-2024-00032
• Device Sequence Number: 1
• Product Code: FNM
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female