MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; WALKER

Model Number 10200-1

Device Problem Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a walker by and end user's wife, who stated "her husband fell down" while using the walker.The reporter stated that the walker's leg was bent, but was unsure whether the leg was bent prior to the fall, or as a result of the fall.She confirmed that her husband did not sustain any injuries, and did not seek any medical treatment.Drive will continue to monitor complaints for any related trends.

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a walker by and end user's wife, who stated "her husband fell down" while using the walker.The reporter stated that the walker's leg was bent, but was unsure whether the leg was bent prior to the fall, or as a result of the fall.She confirmed that her husband did not sustain any injuries, and did not seek any medical treatment.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no 1 jinzhao st, west district; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 17019119
• MDR Text Key: 316113775
• Report Number: 2438477-2023-00048
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117331
• UDI-Public: 00822383117331
• 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,Followup
• Report Date: 05/30/2023,06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10200-1
• Device Catalogue Number: 10200-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2023
• Distributor Facility Aware Date: 05/01/2023
• Event Location: Home
• Date Report to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male