MAUDE Adverse Event Report: DRIVE MEDICAL; ADAPTOR, HYGIENE

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/15/2016

Event Type  Injury  

Event Description

(b)(4) received a letter regarding the incident from the (b)(6), involving a bath chair, a product imported and distributed by (b)(4).While the enduser was using the bath chair, one of the legs allegedly folded and collapsed causing him to fall.The fall allegedly resulted in a fractured rib.(b)(4) is in the process of getting the product back to further the investigation.Device manufacturer information is not available at this time.This report is based on the information that was provided by (b)(6) services.

• Brand Name: DRIVE MEDICAL
• Type of Device: ADAPTOR, HYGIENE
• MDR Report Key: 6508654
• MDR Text Key: 73329707
• Report Number: 2438477-2017-00037
• 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: Other
• Type of Report: Initial
• Report Date: 04/20/2017,03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 04/20/2017
• Distributor Facility Aware Date: 03/23/2017
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other