MAUDE Adverse Event Report: UNKNOWN DRIVE; GRABBAR

Model Number	RTL13084
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: GRABBAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8422031
• Report Number: 2438477-2019-00006
• Device Sequence Number: 2170815
• Product Code: ILS
• UDI-Device Identifier: 00822383246529
• UDI-Public: 822383246529
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section F): 03/14/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL13084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 98
• Date Report Sent to FDA: 03/14/2019