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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; TOILET SUPPORT
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UNKNOWN DRIVE; TOILET SUPPORT Back to Search Results
Model Number RTL12087
Device Problem Break (1069)
Patient Problem Hip Fracture (2349)
Event Date 02/03/2019
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a bath safety device toilet support.There are no pictures of the device.We are not expecting return of device.Consumer is requesting compensation.The unit was received august 2018.The handle broke on the left side and caused her to fall.Fire department called to take her to hospital where she was diagnosed with fractured hip and pelvis.Opted out of hip replacement and had hip repaired.Hospitalized for all of (b)(6).Rehab afterwards.Occupational and physical therapists assisted her every day once she was home in (b)(6).
 
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Brand Name
DRIVE
Type of Device
TOILET SUPPORT
Manufacturer (Section D)
UNKNOWN
MDR Report Key8829133
MDR Text Key152486940
Report Number2438477-2019-00045
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383252841
UDI-Public822383252841
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/25/2019
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
Device Operator Lay User/Patient
Device Model NumberRTL12087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2019
Distributor Facility Aware Date02/26/2019
Device Age1 YR
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age81 YR
Patient Weight91
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