MAUDE Adverse Event Report: HOMECARE ENTERPRISE CO. LTD. ESSENTIAL BATH SAFETY; BATH STOOL

Model Number 5053S

Device Problems Break (1069); Inadequate Service (1564)

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

Event Date 05/24/2016

Event Type  malfunction  

Event Description

User was seated in the shower when this bath stool collapsed.The upper frame broke in the middle.Patient fell but did not suffer any injury.

• Brand Name: ESSENTIAL BATH SAFETY
• Type of Device: BATH STOOL
• Manufacturer (Section D): HOMECARE ENTERPRISE CO. LTD.; no. 11 changsheng st; huatan township; changhua county 50347 ; TW 50347
• MDR Report Key: 5775130
• MDR Text Key: 48978049
• Report Number: 1056127-2016-00005
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00754756140243
• UDI-Public: 754756140243
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016,06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5053S
• Device Catalogue Number: B3100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2016
• Distributor Facility Aware Date: 06/13/2016
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 07/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 116