MAUDE Adverse Event Report: UNKNOWN DRIVE; GRAB BAR

Model Number	RTL13083
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Damage to Ligament(s) (1952)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a grab bar.The end-user acquired the device for assistance in and out of bathtub.She was using the device prior to undergoing a total knee replacement surgery on (b)(6) 2018.The product detached from wall while end user was getting out of the shower.The patient was diagnosed with torn patellar tendon which required surgery and a knee brace for 8 weeks.This procedure took place on (b)(6) 2019.

• Brand Name: DRIVE
• Common Device Name: GRAB BAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8344034
• Report Number: 2438477-2019-00003
• Device Sequence Number: 13911653
• Product Code: ILS
• UDI-Device Identifier: 00822383580876
• UDI-Public: 822383580876
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/14/2019
• Report Date (Section F): 12/15/2019

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: RTL13083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73
• Date Report Sent to FDA: 12/15/2019