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

Model Number SB104

Device Problem Bent (1059)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 07/31/2015

Event Type  malfunction  

Event Description

The end user noted that the leg on his shower bench was bent inward but continued to use it the next day.He fell off the bench while showering, but was not injured.Investigation showed that the unit was mis-assembled.

• Brand Name: ESSENTIAL BATH SAFETY SHOWER BENCH
• Type of Device: SHOWER BENCH
• Manufacturer (Section D): COM-BRIDGE INTERNATION CO., LTD; unit 1, no. 66 yu long 3 road; dongsheng town, zhongshan city; guangdong 52841 4; CH 528414
• Manufacturer (Section G): ESSENTIAL MEDICAL SUPPLY, INC.; 6420 hazeltine national dr.; orlando FL 32822
• Manufacturer Contact: 6420 hazeltine national dr.; orlando, FL 32822
• MDR Report Key: 5008574
• MDR Text Key: 23339216
• Report Number: 1056127-2015-00020
• Device Sequence Number: 1
• Product Code: IKX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SB104
• Device Catalogue Number: B3003
• 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: 08/13/2015
• Distributor Facility Aware Date: 07/31/2015
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 08/13/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 77