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  

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.

• 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: 16768437
• MDR Text Key: 313571374
• Report Number: 1419652-2023-00026
• 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: Other
• Type of Report: Initial
• Report Date: 04/19/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Distributor Facility Aware Date: 03/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention