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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NINGBO SHENYU DRIVE; BATH BENCH
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NINGBO SHENYU DRIVE; BATH BENCH Back to Search Results
Model Number 12486
Device Problem Material Fragmentation (1261)
Patient Problems Fall (1848); Pain (1994)
Event Date 02/13/2019
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a bath bench.The device was in use by the end-user for a year.Pms does not anticipate return of the device for evaluation.Patient requires compensation.The end-user was sitting on chair in his shower and the chair collapsed.The bracket connecting the seat to the legs had failed.His neck and back hit the wall.He injured his tailbone.Physical therapy and a chiropractor was required.He noted that the device was stored in a dry area of the bathroom.
 
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Brand Name
DRIVE
Type of Device
BATH BENCH
Manufacturer (Section D)
NINGBO SHENYU
west of tanjialing road
juyao
zhejiang,, 31540 8
CH  315408
MDR Report Key8458364
MDR Text Key140117811
Report Number2438477-2019-00012
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383108902
UDI-Public822383108902
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2019,03/11/2019
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 Number12486
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2019
Distributor Facility Aware Date03/11/2019
Device Age13 MO
Event Location Home
Date Report to Manufacturer03/29/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient Weight92
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