MAUDE Adverse Event Report: COMBO (ZHONGSHAN) MEDICAL EQUIPMENT DRIVE; COMMODES, FOLDING

Model Number 11148N-4

Device Problem Material Integrity Problem (2978)

Patient Problem Head Injury (1879)

Event Date 02/08/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, drive devilbiss healthcare was notified of an accident involving a drive medical folding steel commode.The end user reported that the center bars supporting the bucket broke free, causing her to fall between the front and back cross bars and sustain injury to her head, back and leg.She reported that she did not seek or require medical attention, and declined to return the product to drive for investigation or evaluation.

• Brand Name: DRIVE
• Type of Device: COMMODES, FOLDING
• Manufacturer (Section D): COMBO (ZHONGSHAN) MEDICAL EQUIPMENT; building 1, no 6 tongxing east; tongxing e. rd, dongsheng town; zhongshan city, guangdong province ; CH
• MDR Report Key: 14022675
• MDR Text Key: 288680699
• Report Number: 2438477-2022-00024
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383227603
• UDI-Public: 822383227603
• 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: 04/06/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11148N-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Event Location: Home
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG