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

Investigation is ongoing, once the investigation conclusion is available, the follow-up report will be submitted.H3 other text : device not identified.

Event Description

A patient developed 2 unstageable pressure injuries allegedly due to the tubing of the dvt garment.No additional details on this event were provided by the customer.Attempts to gather the details are still ongoing.

Manufacturer Narrative

The customer reported that their patient developed 2 unstageable pressure injuries due to the tubing of the garment.The customer was concerned about proper garment positioning and was requesting some additional recommendations.Despite attempts to contact the customer, in order to gather additional details no information was provided.It is unknown what type of garment was used.Based on the photograph provided, it might be a calf garment.However, the customer did not specify the garment used, did not indicate where the injuries were located and did not state whether the garment was used with other equipment.Without additional details, we are unable to address the customer¿s concerned about the positioning of the garments on the patient¿s leg and specify the cause of the reported pressure injuries.Flowtron garment short guidance 04.Dv.00-int2_5 dated 06/2022 states: "garment should be removed regularly to inspect the skin or signs of redness or pressure points."."cautions: garments should be removed immediatly if patient experiencing tingling, numbness or pain."."cautions: lower limb positioning in relations t the garment and tubing should also be considered particularly when a patient is unconscious, or has reduced sensation/ability to move their legs."."cautions: additional car should be taken when placing the garments on any deformed leg or foot, or on legs with significant oedema.".To sum up, the garment was used for the patient treatment, however due to insufficient information received, the relation between the garment and the pressure injury cannot be established.There is no indication that would suggest that the product failed to meet its specification.

• 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: 16768294
• MDR Text Key: 313569480
• Report Number: 3007420694-2023-00081
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• 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