MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BEDSIDE COMMODE; ADAPTOR, HYGIENE

Model Number MDS89664A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abrasion (1689); Erythema (1840); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 07/21/2019

Event Type  malfunction  

Event Description

Patient attempted to use bedside commode, yelled out "something is sharp and it cut me".Writer immediately inspected commode and did not observe anything obvious at first.Patient ambulated to bathroom.Writer inspected back of patient's leg after voiding and observed scant amount of blood and some redness with abrasion on the back of left thigh.Wound was cleaned with normal saline and bandage applied.Writer noticed upon closer inspection that the bsc has two areas of metal that protrude past the commode seat, edges do appear to be sharp.Commode was pulled out of room and signage applied.

• Brand Name: BEDSIDE COMMODE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8964898
• MDR Text Key: 156607956
• Report Number: 8964898
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MDS89664A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32850 DA