MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD. DRIVE DEVILBISS HEALTHCARE; ADAPTOR, HYGIENE

Model Number 12027RA-4BULK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 02/19/2024

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a raised toilet seat by the provider, who stated that the end user fell when the seat came out from under her, and required stitches.The provider reported that the device is not defective but the information suggests that the raised toilet seat may have not been the proper shape for their toilet.The device is not returning for evaluation.Drive devilbiss is investigating the incident and an update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; 1318 west of tanjialing road; yuyao, zhejiang ; CH
• MDR Report Key: 18818337
• MDR Text Key: 336742134
• Report Number: 2438477-2024-00011
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024,03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12027RA-4BULK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2024
• Distributor Facility Aware Date: 02/19/2024
• Event Location: Home
• Date Report to Manufacturer: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 58 KG