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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH
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UNKNOWN DRIVE; BATH BENCH Back to Search Results
Model Number RTL12202KDR
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Loss of consciousness (2418); Insufficient Information (4580)
Event Date 08/22/2019
Event Type  Injury  
Event Description
(b)(6) is the initial importer of the device which is a bath bench.Drive became aware of the incident through a legal notice.We have not received the device for evaluation of root cause.We are filing this report in an overabundance of caution.A follow-up will be submitted when additional data becomes available.The end-user went swimming as part of his recovery from prior back surgery.After finishing swimming, he went to take a shower.When he tried to utilize the chair, he fell and hit his head against the towel wall, then fell hit the other side on the floor injuring his face, jaw, teeth and incurring loss of consciousness.Security called the paramedics and end-user was transported to the hospital.No additional information is available.
 
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Brand Name
DRIVE
Type of Device
BATH BENCH
Manufacturer (Section D)
UNKNOWN
MDR Report Key12081798
MDR Text Key262618106
Report Number2438477-2021-00026
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383247212
UDI-Public822383247212
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberRTL12202KDR
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/28/2021
Distributor Facility Aware Date06/03/2021
Event Location Outpatient Treatment Facility
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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