MAUDE Adverse Event Report: ADLO MANUFACTURING LTD. ULTIMA; BATH CHAIR

Model Number BCU-8720L-BB

Device Problem Material Integrity Problem (2978)

Patient Problem Limb Fracture (4518)

Event Type  Injury  

Event Description

On february 22, 2022, drive devilbiss healthcare identified a comment on amazon that reported an event involving a rollator.The commentor stated that "the front leg collapsed yesterday.My husband is now in the hospital with a hip fracture and is awaiting hip surgery." drive is currently attempting to identify the commenter through amazon, or contact the customer through further commenting, in order to investigate the event, including retrieving the rollator for inspection and evaluation.

• Brand Name: ULTIMA
• Type of Device: BATH CHAIR
• Manufacturer (Section D): ADLO MANUFACTURING LTD.; no. 8 jiannong park; yaoguan town, wujin district; changzhou, jiangsu 21310 0; CH 213100
• MDR Report Key: 14316228
• MDR Text Key: 294161453
• Report Number: 3005328749-2022-00001
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BCU-8720L-BB
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Home
• Date Report to Manufacturer: 05/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 43 KG