MAUDE Adverse Event Report: COM-BRIDGE INTL CO LTD ESSENTIAL BATH SAFETY SHOWER BENCH

Model Number SB112

Device Problem Bent (1059)

Patient Problems Fall (1848); Pain (1994)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

End user stated that he was seated on the shower bench in his bedroom and had bent over to tie the laces on his right shoe when the bench tipped backwards.He fell, injuring his lower back.End user is in possession of the bench and has refused to surrender it for eval.

Manufacturer Narrative

Note from importer: aware date varies from this report date.Initial determination was that the user exceeded weight limit and suffered minor back injury.On (b)(6) 2015 he reported that he was examined at (b)(6) and may need surgery, alleging that this is related to the fall.

• Brand Name: ESSENTIAL BATH SAFETY SHOWER BENCH
• Type of Device: SHOWER BENCH
• Manufacturer (Section D): COM-BRIDGE INTL CO LTD; unit 1 no 66 yu long 3 rd, dongsheng town; zhongshan city, guangdong 5284 14; CH 528414
• MDR Report Key: 4527353
• MDR Text Key: 5356404
• Report Number: 1056127-2015-00003
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2015
• Distributor Facility Aware Date: 02/09/2015
• Event Location: Home
• Date Report to Manufacturer: 02/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 122