MAUDE Adverse Event Report: SAGE PRODUCTS, LLC; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

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

Patient Problems Erythema (1840); Necrosis (1971); Pressure Sores (2326); Unspecified Tissue Injury (4559)

Event Date 03/14/2020

Event Type  malfunction  

Event Description

Patient admitted from emergency dept from assisted living facility (alf) with necrotic sacral wound on left and right sacrum with reddened surrounding skin.As well as reddened abdominal folds left and right.Sacrum necrotic; abdominal folds left and right reddened; only injury is device-related, no other pressure related injuries.Injury notes: device related to perineum, all other bony prominences intact per wound.Treatment notes: barrier skin cream placed on sacrum.The patient is alert and oriented and is able to assist with turning to her side, but does need help to get completely over and stay over.She has urine incontinence.The prima fit was in place.Where the plastic end of the prima fit touched the skin, there is deep tissue injuries (dti) the same shape of the prima fit.The same shape and size of dti is to bilateral perineum between the vaginal opening and the anal opening.The dti is intact skin with yellow slough just under the surface of the skin.No pressure injury to the bony prominences.Patient was admitted from alf and found to have a pressure injury present to the sacral ulcer.Md was notified and wound management consulted.Per wound management note: patient had no pressure injury to the bony prominences however, multiple rns documented a sacral wound every shift until the patient was discharged five days later.Patient is no longer admitted so unable to verify if there actually was a sacral wound or not.Pressure injury prevention protocol was in place while patient was admitted.

• Type of Device: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): SAGE PRODUCTS, LLC; 3909 3 oaks road; cary IL 60013
• MDR Report Key: 12016316
• MDR Text Key: 256724121
• Report Number: 12016316
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32485 DA