MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. COMMODE

Catalog Number MDS89664A

Device Problems Detachment Of Device Component (1104); Disconnection (1171)

Patient Problem Muscle Spasm(s) (1966)

Event Date 02/22/2014

Event Type  Injury  

Event Description

The end user fell when the seat support bars disconnected.

Manufacturer Narrative

As the end user went to sit on the commode, the seat support bars separated and she fell.She was prescribed medication for muscle spasms.The sample was returned and evaluated.It was confirmed that the right and left commode bucket support bars had disconnected from the unit.The bars are a non weight bearing component of the device and should not fail prematurely.The facility reported that the end user took the assembled device home with her when she was discharged from the hospital.When it would not fit in her car, they believe she removed the legs for easier transportation home.It is not known if she reassembled it correctly or if it was damaged during transportation.A root cause has not been determined.We have had no other similar complaint for this device.

• Brand Name: COMMODE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3874913
• MDR Text Key: 4461415
• Report Number: 1417592-2014-00059
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/06/2014

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS89664A
• Device Lot Number: C131112477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 70