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

Model Number 10247-4

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a complaint involving a walker from an end user, who reported that while using the walker, it "slid," causing her to fall.The end user stated that "with all the narcotics in her body, [she] shouldn't have to worry about the surfaces [she] walks on." she stated that to her knowledge "nothing on the unit is broken but left a skid mark on her floor." as a result of the fall, she hit the left side of her head and "ruptured her ear." drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 15476886
• MDR Text Key: 300572378
• Report Number: 3014644996-2022-00014
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 50822383537257
• UDI-Public: 50822383537257
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2022

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?: No
• Device Model Number: 10247-4
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female