MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; WALKER

Model Number 10211-1

Device Problem Fracture (1260)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 09/13/2021

Event Type  Injury  

Event Description

(b)(4) healthcare is the initial importer of the device which is a walker.The device has not been returned for evaluation currently.A follow-up report will be filed when additional information becomes available.We are submitting this report in an overabundance of caution.The device's left leg gave way while the user was walking down the hallway.The user fell and the device landed on top of her.The nurse assisted her and she was taken to the physical therapist for evaluation.There is a concern for internal injuries as the user is on blood thinners.They are monitoring her.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road,; dongsheng town,; zhongshan cit, guangdong, 52841 4; CH 528414
• MDR Report Key: 12680854
• MDR Text Key: 277870243
• Report Number: 2438477-2021-00065
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383231037
• UDI-Public: 822383231037
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/21/2021,10/22/2021

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 Operator: Lay User/Patient
• Device Model Number: 10211-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2021
• Distributor Facility Aware Date: 09/13/2021
• Device Age: 5 YR
• Event Location: Nursing Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR
• Patient Weight: 57