MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. L501-M GARMENT; SLEEVE, LIMB, COMPRESSIBLE

Model Number L501-M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer raised a complaint stating that the patient sustained deep tissue injury to the heel.Upon further clarification it became unclear whether the arjo equipment was involved or contributed to the event, but the complaint was decided to be reported in abundance of caution due to patient outcome.

Event Description

The customer reported that the patient sustained heel deep tissue injury (dti) and the lateral right leg wound.The arjo garment l501-m and flowtron acs900 pump were used at the time of the event.The customer complained that the garment tubing is allegedly causing pressure injuries, as it comes out of the back of the product rather than on the front side.There is no report of any device malfunction.No further details were made available regarding this event.

Manufacturer Narrative

Based on the collected information the root cause of the investigated event cannot be established.The patient was very ill at the time of event and was given pressors, the patient's condition could have had impact to the skin condition.There is no report of any device malfunction.The instructions for use for flowtron garments (04.Dv.00.Row rev.3) includes the following information related to garment positioning during use: "garments should be removed regularly to inspect the skin for signs of redness or pressure points", lower limb positioning in relation to the garment and tubing should also be considered particularly when patient is unconscious or has reduced sensation / ability to move their leg".Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.There is no indication of any device malfunction at the time of the event.This complaint is deemed reportable due to injury sustained by the patient - deep tissue injury on one heel.

• Brand Name: L501-M GARMENT
• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12975999
• MDR Text Key: 282281843
• Report Number: 3007420694-2021-00166
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: L501-M
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other