MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD. DRIVE; CRUTCH

Model Number 10403

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/01/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a crutch.Forearm crutch allegedly broke at the 5th hole from the bottom during use.End-user reopened incision on recently amputated left leg.

• Brand Name: DRIVE
• Type of Device: CRUTCH
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD.; yi he civil affairs industrial; guongdong; guangdong, 51602 3; CH 516023
• MDR Report Key: 6826647
• MDR Text Key: 83859575
• Report Number: 2438477-2017-00071
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/29/2017,08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10403
• 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: 08/29/2017
• Distributor Facility Aware Date: 08/01/2017
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 08/29/2017
• 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: 33 YR
• Patient Weight: 91