MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number 790

Device Problem Solder Joint Fracture (2324)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 11/30/2018

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a knee walker.The unit was not returned to drive for evaluation.We are filing this report in an overabundance of caution.We will file a follow-up when additional information becomes available.The end user rented a knee walker in the course of his recovery from a left tibia and fibula fracture that had required surgery.He fell on his right side when the seat post snapped during use.As per mri results, he suffered a retracted tear of the right long head bicep tendon and a likely partial tear of the right rotator cuff.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11631596
• MDR Text Key: 244387318
• Report Number: 2438477-2021-00010
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• 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: 04/07/2021

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: 790
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2021
• Distributor Facility Aware Date: 06/02/2020
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 104