MAUDE Adverse Event Report: DRIVE MEDICAL; ADAPTOR, HYGIENE

Model Number RTL12203KDR

Device Problems Bent (1059); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/11/2016

Event Type  Injury  

Event Description

(b)(6) received notice regarding the incident from the enduser, involving a shower bench, a product imported and distributed by (b)(6) healthcare.The shower bench was assembled by herself and her daughter.After the chair was assembled, her daughter noticed that the chair did not look right because the legs were slanted in a little.The enduser stated that she still decided to use the shower bench.While the enduser was using the shower bench the leg buckled causing her to fall onto the floor and hurt her back.An x-ray was taken which showed that she had a fracture in her vertebrae.The fracture will need to be filled with cement.(b)(6) has reached out to the enduser to collect additional information and the returning of the alleged product for investigation, however the enduser stated that her attorney advised her to not send the product back to (b)(6).Due to lack of product information, we are unable to identify the manufacturer of the product.The report is based on the information that was provided by the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: ADAPTOR, HYGIENE
• MDR Report Key: 6248146
• MDR Text Key: 64715293
• Report Number: 2438477-2017-00001
• 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: Patient
• Type of Report: Initial
• Report Date: 01/12/2017,07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL12203KDR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2017
• Distributor Facility Aware Date: 12/15/2016
• Event Location: Home
• 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: 70 YR
• Patient Weight: 82