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

Model Number	FG100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported to the swedish medical products agency, the following: "fg 200 has been put on so that wading is missing over area for n.The course of the peroneus over the ankle." "sensory impairment over the big toe and adjacent toe.Drop foot when inversion ability reduced." the customer reported in their report that the patient was using garment size fg200.However, lot number provided, indicates that the garment that was used was fg100.The difference between those two garments refer to foot size.Fg is smaller than fg200.Information along with pictograms regarding garments size, and how to apply the garments onto the foot are included in the product instruction for use, garment sizing and application guide, also garment has printing showing the size and proper application.The guidance and instructions for use are delivered to the customer with every garment delivery.The photographic piece of evidence provided shows that the garment was placed on the heel part of the foot, which is not in accordance to the product labelling.The foot garment has four flaps, two flaps are folded over the single flap on the top of the foot.The fourth flat goes around the heel.The customer stated that the garment was placed in a way, that the fourth flap was not around the heel.Additionally, in regards to comfort while using the garment, instructions state: ¿garment should be removed regularly to inspect the skin¿ ¿where appropriate, patients should be instructed in the proper use of the system, the purpose of therapy, and any problems that should be reported to the nursing staff¿ ¿garment should be removed immediately if the patient experiences tingling, numbness or pain¿.Arjo sales representative visited the customer to discuss the complaint.The customer agreed that the issue is related to handling errors.There was no product failure.Taking all the facts into consideration, the issue is concidered user error with no other device performance issue.

• Brand Name: DVT FOOT GARMENTS
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 21172527
• Report Number: 1419652-2025-00007
• Device Sequence Number: 4276576
• Product Code: JOW
• UDI-Device Identifier: 05055982700757
• UDI-Public: (01)05055982700757(10)2002678006(11)230330
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2025
• Report Date (Section F): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FG100
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2024
• Event Location: Home
• Date Report to Manufacturer: 01/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/16/2025