MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT ESSENTIAL BATH SAFETY SHOWER CHAIR

Model Number B005

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 08/06/2020

Event Type  Injury  

Event Description

Patient was in shower when leg of shower bench started to collapse.He grabbed for the safety bar in the shower but did not fall, he did not seek medical attention.One week later his shoulder started to hurt.On (b)(6) 2020 he was contacted by his cardiologist stating that the monitoring system for his newly installed defibrillator lead had come loose.Surgery was performed on (b)(6) 2020 to reconnect the lead.The relationship between the bend in the leg of the bath stool and the disconnecting of the defibrillator lead in this case is not established so this medwatch report is being filed in an abundance of caution.

• Brand Name: ESSENTIAL BATH SAFETY SHOWER CHAIR
• Type of Device: SHOWER CHAIR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT; no 1318 west of tanjialing rd; yuyao city, zhejiang 31540 8; CH 315408
• MDR Report Key: 10583086
• MDR Text Key: 208500449
• Report Number: 1056127-2020-00008
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00754756131500
• UDI-Public: 754756131500
• 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: 09/24/2020,08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B005
• Device Catalogue Number: B3002-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Distributor Facility Aware Date: 08/20/2020
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86