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

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within follow-up report once the investigation is completed.

Event Description

Following the information provided the customer complained that the patient sustained deep tissue injury, that possibly developed to unstageable ulcer, during use of arjo dvt calf garment.The injury was assessed as serious.The customer did not provide the details regarding event circumstances.

Manufacturer Narrative

An arjo sale representative received a call from the wound care nurse that the arjo dvt l-501m garments tubing have caused pressure injuries to few patients.In the follow -up communication with the customer to complaint # (b)(4) (medwatch #3007420694-2022-00062), we have learned that 5 patients in total, at (b)(6) hospital sustained deep tissue injuries lateral and/or medial malleolus and some developed into unstageable pressure injuries.All the complaints have been submitted to the fda under medwatch # 3007420694-2022-00062, 3007420694-2022-00067, 3007420694-2022-00068, 3007420694-2022-00069, 3007420694-2022-00070 this summary concerns complaint tw(b)(4) (medwatch #3007420694-2022-00067).The customer reported that these 5 events go back 10 years.Patients were elderly age, and mostly calf garments were used in intensive care unit.Some of the patients were wearing sage heel boots, however, the nurse did not know whether or not they were used by the patients who sustained the injuries.According to the customer, garments were removed daily, every shift, to assess the patients skin.The locations of all injuries were the same- lateral and medial malleolus.In our investigation we could not determine why the tubing caused the injuries as there are many factors which may have contributed to the pressure injuries, such as: incorrect size of garments used, the improper positioning of a garment causing that the tubing is creating a pressure points on the patient's limb, improper tubing routing while using heel boots, insufficient patient skin monitoring.In the labelling arjo specifies how and where to place garment and tubing and provides guidance of using the garments.The guidelines can be found in flowtron acs900 instructions for use.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".Taking into account that the 5 events occurred over 10 years, we are unable to determine the cause of the reported injuries from garment tubing and assess whether any relationship, between the way the tubing is placed on the garment and the patient's injury, exists.Taking into account a high turnover of the staff, arjo representative offered a re-education session, but this was declined by the customer.In summary, patients sustained a serious pressure injuries from tubing while using arjo garment and from that perspective arjo device failed to meet its performance specification.However, there was no indication of product failure and the cause of the injuries could not be determined as there are many factors that can influence the injuries.The arjo product played a role in the event.We report this event due to allegation of serious injury occurrence.H3 other text : product not available, the incidents go back 10 years.

• 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: 14460847
• MDR Text Key: 294657697
• Report Number: 3007420694-2022-00067
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• 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