MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. DVT CALF GARMENTS STANDARD; SLEEVE, LIMB, COMPRESSIBLE

Model Number TBD

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

It was reported that a patient had received a pressure injury after using dvt garments.This injury was found from inside the stocking.The bottom part where the cloth is but it was the end of the tubing.

Manufacturer Narrative

A patient sustained deep tissue injury on the right leg achilles during the use of arjo calf garment.During the use of the arjo device, also the patient used scd stocking and heel protector boots¿ third-party equipment.The injury was noted when a nurse assessed a patient on morning rounds and noted on the back achilles a deep tissue injury.The injury occurred in the place where the garment tubing was inside the stocking.The customer alleged that the pressure injury resulted from the pressure points created by the garment tubing.The arjo representative contacted the customer, however, no other information regarding the event was provided.There was no indication of an arjo product malfunction.In the labelling arjo specifies how and where to place garment and tubing and provides guidance of using the garments.For example the guidelines can be found in flowtron acs900 instructions for use (526933en).This document, inter alia, states that: "the system should be combined with an individualised monitoring programme"."this system represents one aspect of a dvt strategy; if the patient's condition changes, the overall therapy regimen should be reviewed by the prescribing clinician" "garments should be positioned in such a way that they do not create any potential for constant pressure points on the patient's limb.If using apparatus with straps or securing devices,[¿] make sure that the tubing is not placed inside the strap next to the patient's skin, and regularly check the patient's skin for signs of redness or pressure points"."lower limb positioning in relations to the garment and tubing should also be considered particularly in a patient that is unconscious, cannot feel or has reduced sensation and/or ability to move their leg(s)"."the patient's skin should be inspected frequently during every shift"."clinical judgement is required to determine if the patient's skin condition requires additional protective measures, or if the therapy should be discontinued and an alternative modality used".In summary, based on the above, it is considered that possibility, the use of the scd stocking in combination with inappropriate tube positioning contributed to the development of pressure injury.Arjo's garment was used for treatment when the injury occurred and from that perspective, it played a role in the event.The patient sustained a serious pressure injury and therefore arjo garment is considered not to meet its performance specification, most likely due to the way the tubing was routed.

• Brand Name: DVT CALF GARMENTS STANDARD
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• 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: 16093239
• MDR Text Key: 306589216
• Report Number: 3007420694-2023-00007
• Device Sequence Number: 1
• Product Code: JOW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TBD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• 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: 92 YR
• Patient Sex: Male