MAUDE Adverse Event Report: UNKNOWN DRIVE; GRABBAR

Model Number RTL13084

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

(b)(4) is th initial importer of the device which is a grabber.The end-user grabbed the bar when the green indicator was activated.However the pin wasn't in there and the person fell he went tot he emergency room.The patient was injured.C3- c6 bones and is currently doing physical therapy.He may need surgery later on.The patient is 6ft and (b)(6).He has been using the device for 2 months.

• Brand Name: DRIVE
• Type of Device: GRABBAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8422031
• MDR Text Key: 138834585
• Report Number: 2438477-2019-00006
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246529
• UDI-Public: 822383246529
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL13084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2019
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 98