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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD CAREX; ADJUSTABLE BATH & SHOWER SEAT
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NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD CAREX; ADJUSTABLE BATH & SHOWER SEAT Back to Search Results
Model Number FGB65100 0000
Device Problem Unstable (1667)
Patient Problem Bone Fracture(s) (1870)
Event Date 12/27/2013
Event Type  Injury  
Event Description
On (b)(6) 2013 the end-user had major surgery.On (b)(6) on his neck and spine.The end-user's wife checked to make sure the bolts were tightened on the shower seat.The wife turned around, and the end-user had slid right off of the chair and fell out of the tub, breaking a rib.The end-user could not attend physical therapy for 6 weeks until the rib had healed.The end-user was on pain medication.The end-user did not use the shower seat for 3 weeks after the incident, as the legs were bending out.On 08/27/2015 (b)(4) sent letter to compass health brands.On 6/2/2016 the complaint was revisted by the (b)(4) to compass health brands, and a case was opened in the complaint management system for tracking purposes.
 
Event Description
Supplier information regarding malfunctioning device made available (fgb65100 0000 adjustable bath & shower seat).
 
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Brand Name
CAREX
Type of Device
ADJUSTABLE BATH & SHOWER SEAT
Manufacturer (Section D)
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD
west of tanjialing road
yuyao zhejiang, 31540 8
CH  315408
MDR Report Key5740045
MDR Text Key47892290
Report Number3005182235-2016-00008
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 06/21/2016,10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFGB65100 0000
Device Catalogue NumberB651-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2016
Distributor Facility Aware Date08/27/2015
Event Location Home
Date Report to Manufacturer01/31/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Weight120
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