MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO., LTD ESSENTIAL BATH SAFETY SHOWER BENCH

Model Number SB112

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

Patient's wife was using a shower bench which the husband described as unstable.She fell off and hit her head.No serious injury reported.Examination of the bench showed that one leg sat approximately 0.5" off the ground when other three legs were in touch with the surface.

• Brand Name: ESSENTIAL BATH SAFETY SHOWER BENCH
• Type of Device: SHOWER BENCH
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO., LTD; unit 1, no. 66 yu long 3 road; dongsheng town; zhongshan city, guangdong 5284 14; CH 528414
• MDR Report Key: 4762929
• MDR Text Key: 15392864
• Report Number: 1056127-2015-00009
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SB112
• Device Catalogue Number: B3014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2015
• Distributor Facility Aware Date: 04/17/2015
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 05/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 79