MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH CHAIR

Model Number RTL12202KDR

Device Problem Material Fragmentation (1261)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 04/05/2019

Event Type  Injury  

Event Description

(b)(6) healthcare is the initial importer of the device which is a shower chair.We have received photos but not the return of the product.The back of the seat broke while in use.The enduser fell in the shower between the chair and the wall.The enduser previously had fusion surgery on his neck and back.The fall exacerbated injuries to neck and back.He has been treated for the pain.

• Brand Name: DRIVE
• Type of Device: BATH CHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8698290
• MDR Text Key: 148002029
• Report Number: 2438477-2019-00031
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 822383247212
• 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: 06/13/2019

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: 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: 06/13/2019
• Distributor Facility Aware Date: 04/24/2019
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 104