MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT DRIVE; COMMODE

Model Number	11148-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a commode.We are still awaiting return of the device for evaluation.According to daughter, her mother fell while using the device in the evening.She had a laceration in the back of her head from the fall.They took her to the hospital to have her checked out.Per daughter, the front right leg on the commode is longer than the left leg.

• Brand Name: DRIVE
• Common Device Name: COMMODE
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 9158354
• Report Number: 2438477-2019-00066
• Device Sequence Number: 2622806
• Product Code: ILS
• UDI-Device Identifier: 50822383222030
• UDI-Public: 50822383222030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019
• Report Date (Section F): 10/04/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 11148-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2019
• Device Age: 22 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 10/04/2019