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

Model Number TBD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 10/11/2022

Event Type  Injury  

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.

• 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
• MDR Report Key: 16093237
• MDR Text Key: 306593033
• Report Number: 1419652-2023-00002
• 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: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2023
• Distributor Facility Aware Date: 12/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male