MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE; SHOWER CHAIR WITH FOLDING BACK

Model Number RTL12606

Device Problem Material Integrity Problem (2978)

Patient Problem Head Injury (1879)

Event Date 06/23/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a report regarding an incident involving a shower chair with folding back from an end user, who stated that the chair "fell apart while she was in the shower" because it "split down the side." the end user reported hurting her back and hitting her head.An ambulance arrived on scene and checked the end user, but she did not go to the hospital.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.Drive will update this filing if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: SHOWER CHAIR WITH FOLDING BACK
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 15043690
• MDR Text Key: 296078647
• Report Number: 2438477-2022-00068
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383525891
• UDI-Public: 00822383525891
• 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: 07/18/2022

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 Model Number: RTL12606
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Distributor Facility Aware Date: 06/23/2022
• Date Report to Manufacturer: 07/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 120 KG