MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; SWIVEL SEAT SHOWER STOOL

Model Number RTL12061M

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a swivel seat shower stool by an end user, who stated "the plastic part of upper leg broke away, split at seam," causing her to fall in the tub.Paramedics were called for lift assist, but she did not sustain any injuries that warranted transport to the hospital.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: SWIVEL SEAT SHOWER STOOL
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 15605898
• MDR Text Key: 301737452
• Report Number: 2438477-2022-00109
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383541921
• UDI-Public: 00822383541921
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RTL12061M
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Distributor Facility Aware Date: 09/15/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 122 KG