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

Model Number 11148-4

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

Patient Problem Laceration(s) (1946)

Event Date 07/20/2019

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 161939212
• Report Number: 2438477-2019-00066
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 50822383222030
• UDI-Public: 50822383222030
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 11148-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Distributor Facility Aware Date: 08/06/2019
• Device Age: 22 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization