MAUDE Adverse Event Report: UNKNOWN DRIVE MEDICAL; CRUTCH

Model Number 10402-1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 03/17/2016

Event Type  Injury  

Event Description

(b)(6) received notice regarding the incident from the provider involving crutches, a product imported and distributed by drive medical.Allegedly the rubber part at the bottom of the crutch tore through, so when the enduser stepped onto the tile floor she slipped and landed on her broken foot.She went to the hospital and allegedly reinjured her broken foot.Due to lack of product information, we are unable to identify the nature of the defect for this product.This report is based on the information provided from the provider.

• Brand Name: DRIVE MEDICAL
• Type of Device: CRUTCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5583195
• MDR Text Key: 42850968
• Report Number: 2438477-2016-00019
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/15/2016,03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10402-1
• 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: 04/15/2016
• Distributor Facility Aware Date: 03/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 74