MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; BATH SAFETY

Model Number RTL12202KDR

Device Problem Break (1069)

Patient Problem Easy Bruising (4558)

Event Date 06/23/2021

Event Type  Injury  

Event Description

(b)(6) is the initial importer of the device which is a bath safety seat.We have not received the product back for evaluation.Weight capacity of the products equal to the customer's reported weight.A follow-up submission will be filed when additional data becomes available.The device failed upon initial use when the back legs snapped off.User hit her head, hand and neck were bruised.

• Brand Name: DRIVE
• Type of Device: BATH SAFETY
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; 64 & 96 zyaoyi road; dongshan town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 12241808
• MDR Text Key: 265383926
• Report Number: 2438477-2021-00031
• Device Sequence Number: 1
• Product Code: ILS
• 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: 07/28/2021,07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL12202KDR
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2021
• Distributor Facility Aware Date: 06/23/2021
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 136