MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE; ADAPTOR, HYGIENE

Model Number RTL12202KDR

Device Problem Material Integrity Problem (2978)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bath bench by the end user, who reported that the leg of the device broke while in use causing her to fall.She reportedly "hit her left hip and hurt her lower back where [a prior] surgery was" and "is in excruciating pain, she cannot move at all, can't lift her legs, spread her legs apart." drive devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 18547528
• MDR Text Key: 333315502
• Report Number: 2438477-2024-00005
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 00822383247212
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2024
• Distributor Facility Aware Date: 01/04/2024
• Event Location: Home
• Date Report to Manufacturer: 01/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 115 KG